The Master Formula Record (MFR) and Bill of Material (BOM) are essential documents in the pharmaceutical industry, providing comprehensive details for the formulation and manufacturing of pharmaceutical products.
The MFR outlines the specific ingredients, quantities, and procedures required to produce a drug, ensuring consistency and compliance with regulatory standards.
The BOM complements the MFR by listing all raw materials, components, and packaging needed for production, facilitating efficient inventory management and cost control.
Together, these documents are crucial for maintaining quality assurance and streamlining the manufacturing process in pharmaceutical operations.
SOP for Master Formula Record (MFR) and Bill of Material (BOM)
1.0 PURPOSE
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- The Purpose of this Standard Operating Procedure (SOP) is to describe the procedure for the preparation of MFR and BOM for drug products.
2.0 SCOPE
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- This SOP applies to preparing the Master Formula Record (MFR) and Bill of Material (BOM) for all drug product manufacturing.
3.0 RESPONSIBILITY
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- Production/ Packing shall be responsible for:
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- Preparation of the MFR/BOM as per technology transfer documents.
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- Preparation of the MFR/BOM as per the approved SOP.
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- Checking all technical contents mentioned in the MFR/BOM.
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- Impart training to concern department.
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- Quality Assurance shall be responsible for:
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- Checking all technical contents mentioned in the MFR/BOM.
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- Maintenance of approved MFR/BOM and master list of MFR/BOM.
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- Archival and retrieval of a controlled copy of MFR/BOM.
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- Obsolete MFR/BOM master copy and destruction of retrieved controlled copy.
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- Research & Development (R&D) shall be responsible for:
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- Checking all contents mentioned in the Raw Material BOM.
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- Generation of new product ID.
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- The packaging and Development (P&D)/QC packing section shall be responsible for:
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- Checking of packing material’s BOM as per master document.
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- The production Head shall be responsible for:
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- Review and Approval of Master Formula Record (MFR)/Bill of Material (BOM).
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- Review and check the Bill of Material (BOM).
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- Head QA shall be responsible for:
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- Review and Approval of MFR/BOM.
4.0 PROCEDURE FOR PREPARATION OF MFR AND BOM
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Master Formula Record (MFR) & Bill of Material (BOM):
- A document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls.
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- A formally authorized master formula & bill of material shall exist for each product and/or batch size to be manufactured.
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- A common Master Formula Record (MFR) can be prepared for products having the same generic name, same pharmacopoeial standard, same formulation, same manufacturing process & same batch size but different brand names.
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- Guide to Master Formulae Guidance Document from regulatory refer as Annexure-I.
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The master formula for the manufacturing process should include:
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- The name of the product, with a product reference code relating to its specification.
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- A description of the dosage form, strength of the product, and batch size.
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- A list of all starting materials to be used (if applicable), with the amount of each, described using the designated name and a reference that is unique to that material (mention should be made of any substance that may disappear in the course of processing).
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- A statement of the expected final yield with the acceptable limits, and of relevant intermediate yields, where applicable.
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- A statement of the processing location and the principal equipment to be used.
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- The methods, or reference to the methods, are to be used for preparing and operating the critical equipment, e.g. cleaning (especially after a product change), assembling, calibrating, sterilizing, and use.
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- Detailed step-wise processing instructions (e.g. checks on materials, pretreatments, sequence for adding materials, mixing times, temperatures).
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- The step-wise process flow chart.
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- The instructions for any in-process controls with their limits.
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- Where necessary, the requirements for storage of the products, including the container, the labeling, and any special storage conditions.
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- Any special precautions are to be observed.
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- The hold time permitted for intermediate and in-process material.
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The master formula for the packaging process should include:
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- Formally authorized packaging instructions should exist for each product, pack size, and type.
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- The name of the product.
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- A description of its pharmaceutical form, strength, where applicable, and method of application.
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- The pack size is expressed in terms of the number, weight, or volume of the product in the final container.
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- A complete list of all the packaging materials required for a standard batch size, including quantities, sizes, and types, with the code or reference number relating to the specifications for each packaging material.
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- Where appropriate, an example or reproduction of the relevant printed packaging materials and specimens, indicating where the batch number and expiry date of the product have been marked.
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- Special precautions are to be observed, including a careful examination of the packaging area and equipment to ascertain the line clearance before and after packaging operations.
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- A description of the packaging operation, including any significant subsidiary operations, and equipment to be used.
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- Details of in-process controls with instructions for sampling and acceptance limits.
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Preparation of Master Formula Record (MFR)
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- MFR for each product to be manufactured shall prepared according to the procedure defined in this SOP and format no. 4 as “Template for preparation of MFR”.
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- In case of the new product, new/ revised formulation, based upon the data obtained during the Process design stage of the product, MFR shall be prepared, checked by R&D, and approved by the R&D head.
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For the preparation of MFR/BOM, page setting and font style shall conform to the following;
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Paper Size | A4 |
Top Margin | 0.5” |
Bottom Margin | 0.85” |
Left Margins | 1” |
Right margins | 0.5” |
Gutter | 0” |
Header from edge | 0.5” |
Footer from edge | 0.2” |
Font type | Times New Roman |
Font Size | 11 pt. |
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- In the case of existing products, other manufacturing sites (s) shall provide the technology transfer documents including the Master Formula Record (MFR).
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- These technology transfer documents including Master Formula Record (MFR) shall be shared by R&D/other manufacturing sites with the respective manufacturing site as per SOP for Technology Transfer.
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- Based upon technology transfer from R&D/ other manufacturing site, the respective site shall initiate the change control and prepare MFR.
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The list of MFR/BOM shall be maintained as per reference format No. 7.
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- The numbering system of the Master Formula Record (MFR) prepared by R&D shall be done as per the following alphanumeric sequence.
R&D/MFR/AAAA/BB
Where,
R&D : Research & Development
MFR: Master Formula Record
AAAA: Product code which is given by R&D at the time of development. This four-digit product ID.
BB: Two-digit serial number of MFR for a product.
For example, MFR No. for Ambrodil LS Syrup (Product ID 949) shall be R&D/MFR /0949/01
NOTE:- MFR prepared by R&D shall cover all the details up to the manufacturing stage in detail.
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- The numbering system of MFR prepared at respective manufacturing locations shall be as per the following alphanumeric sequence.
MFR/SFGC/XX-RR
Where,
MFR: Master Formula Record
SFGC: Stands for Semi-finished goods code assigned.
XX: Stand for Serial number of MFR Example- 01, 02, 03 …. and so on.
RR: Stand for the revision number of MFR eg. 00, 01, 02, 03 so on
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- An original copy of the Master Formula Record (MFR) shall be maintained by QA.
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- After approval of MFR, Issuance, retrieval, and destruction of records shall be maintained as per format no. 03.
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Preparation of Bill of Material (BOM)
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- Raw Materials (RM) and Packing Materials (PM) BOM shall be prepared by production/ packing personnel based on Technology Transfer/ MFR as per format no. 01 & 02 for Oral Solid Dosage (OSD) forms and format no. 05 & 06 for Injections.
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- The numbering of BOM shall be done as per the following alphanumeric sequence.
BOM/SFGC/RM/XX-ZZ OR BOM/AA/FGC/PM/XX-ZZ
Where,
BOM: Bill of Material
SFGC: Stands for semi-finished goods code assigned
RM: Stands for Raw Material.
PM: Stand for Packing Material.
XX: Stand for serial nos. of MFR e.g. 01,02,03….so on.
ZZ: Stand for the revision number of MFR e.g. 00, 01, 02, 03 so on
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- The finished goods code for Different pack styles (like Sale/PS, for domestic or export) is different therefore PM BOM shall be prepared for each pack style.
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Subsequent serial numbers as 02, 03………n shall be given for the next Bill of Material (BOM) for a product in the following circumstances but not limited to;
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- More than one batch size for a product
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- Changes in packing style.
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- Country-specific BOM. (If Applicable)
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- RM-BOM: BOM shall be prepared by production, and checked by production, QA & R&D (sent to R&D through post/ Email).
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- After receiving of checked Bill of Material (BOM) from R&D, the Production Head and QA Head shall approve the BOM.
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- PM-BOM: BOM shall be prepared by packing, checked by packing, QA, and P&D/QC.
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- Finally Packing and QA Head shall approve the BOM.
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- Original copy of approved BOM shall be maintained by QA and controlled copies shall be sent to the Production /Packing department, Stores, and IPQA department.
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- After approval of BOM, Issuance, retrieval, and destruction of records shall be maintained as per format no. 03.
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- The verified copy of SAP generated Bill of Material (BOM) shall be kept & maintained along with the Original copy of the BOM approved.
5.0 ATTACHMENTS – MASTER FORMULA REPORT (MFR) & BOM
Format No. 01: Template for Preparation of RM-BOM (Oral Solid Dosage forms)
QUALITY ASSURANCE DEPARTMENT | ||||||||||||
BILL OF MATERIAL – RAW MATERIAL | ||||||||||||
Generic Name | ||||||||||||
Product Name | ||||||||||||
Market | BOM No. | Supersedes | ||||||||||
Product Code (Semi-finished) | MFR No. | Supersedes | ||||||||||
Batch Size | Shelf Life | Page No. | ||||||||||
S. No. | Material Code | Material Name | Spec. | Qty./Unit (mg) | Overages | Qty./ Batch | Unit | |||||
Stage : | ||||||||||||
Stage : | ||||||||||||
Stage : | ||||||||||||
Total | Total | |||||||||||
Coating : | ||||||||||||
Total | Total | |||||||||||
Note:
* Actual quantity will be based on Assay and LOD of API. ** The actual quantity to be adjusted will be based on the actual quantity of API. |
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Reason for Issue/Revision : | ||||||||||||
NOTE: In the case of Oral Liquid/ Dry Powder – the coating Stage is not applicable |
Format No. 02: Template for Preparation of PM-BOM (Oral Solid Dosage forms)
QUALITY ASSURANCE DEPARTMENT |
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BILL OF MATERIAL – PACKING MATERIAL |
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Generic Name | |||||||||
Product Name | |||||||||
Product Code (Finished Goods) | BOM No. | Supersedes | |||||||
Market | MFR No. | Supersedes | |||||||
Batch Size | Shelf Life | Page No. | |||||||
Primary Pack | |||||||||
Secondary Pack | |||||||||
Tertiary Pack | |||||||||
Sr.
No. |
Material Code | Material Name | Qty./Batch | Unit | |||||
Primary Packing | |||||||||
Secondary Packing | |||||||||
Tertiary Packing | |||||||||
Reason for Issue/Revision : |
Format No. 03: MFR/BOM Issuance, retrieval & destruction record
Product/ Generic Name: Product Code:
Issuance Record | Retrieval & Destruction record | |||||||
Sr. No. | Revision No. | Control
Copy No. |
Issued To | Issued On | Acknowledgment of Recipient | Date | Done By | Checked By |
Format No. 04: Template for Preparation of Master Formula Record (MFR)
Cover Page
MASTER FORMULA RECORD (MFR) | ||
GENERIC NAME | ||
PRODUCT NAME | ||
PRODUCT CODE | Semi Finished | |
Finished | ||
MFR NO. | ||
BATCH SIZE | ||
DATE OF ISSUE | ||
NO. OF PAGES
(Excluding this page) |
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Address of Manufacturing Site |
Contents of MFR
The MFR shall be prepared under the following sections, as per the sequence:
Sr. No. Description Page No.
- General Guideline
- Product information
- Revision History
- Manufacturing Process Flow Chart
- Formulation Order
- Batch Formula (Stage wise)
- List of Equipment & Instruments
- Environmental Conditions
- Special Precautions
- Manufacturing Methodology
- In-process Testing and Release
- Recovery Procedure
- Specification of Raw Materials.
- Specification of Packing materials (Sale/PS)
- Packing instructions
- General Instructions
- Batch Packing Material
- List Of Equipment & Instruments
- Over Printing Instructions
- Packing Instructions
- Packing material Reconciliation
- Batch Yield Reconciliation
Description & Details to be covered under each section defined under “contents of MFR”.
1.0 General Guideline
This is a MASTER DOCUMENT for ‘PRODUCT NAME’ authorized personnel from the Production, Packing and Quality Department should thoroughly read this document.
Any change to this MASTER DOCUMENT will be made as per quality guidelines, and reworking will be permitted for failing batches with the consent of the Quality Department.
The procedure for reworking will be decided by the Production in-charge and subsequently approved by the Quality Assurance in charge depending upon the nature of the problem.
Any change to be made in the packing components or procedure should be discussed with and approved by QA In-charge and Production In-charge.
2.0 Product Information
1. Generic Name: Describes the Generic Name of the product. |
2. Product Name: Product name is the Brand name so describes the Brand Name of the Product |
3. Dosage Form: Describes the Dosage form of the product i.e. Tablets, Capsules. |
4. Pharmacopoeial reference: Pharmacopoeial reference i.e. IP, BP, USP, or In-house (IH). |
5. Composition: This section includes the label claim of the dosage form. |
6. Strength (Label Claim): Describes strength/amount of active ingredient per unit dose. |
7. Therapeutic Category: Describes the pharmacological action of the product. |
8. Description: Physical description of the finished dosage form. |
9. Dosage: Describes the dosage direction. |
10. Storage Condition: As mentioned on the finished pack. |
11. Shelf Life: Describes the shelf life of the product in months. |
Pack As Pack Style |
12. Packing Profile Sale : |
PS : |
13. Schedule Information: Describes the Schedule information about the drug product. |
14. Mfg. Lic. No. : Describes the manufacturing license number |
15. Manufacturing location: Describe the approved manufacturing location’s full address. |
16. Standard Batch Size: In units/numbers, i.e. 2.0 lac of tablets/vials/capsules, etc. |
17. Standard Specification: Specification Nos. of Raw Material and semi-finished and Finished Products. |
3.0 Revision History
Revision No. | Reason for Revision | Effective Date | Approved By |
- Manufacturing Process Flow Chart: The manufacturing process flow chart shall be made from dispensing to transfer to the finished goods store.
- Formulation Order
- Batch Formula (Stage wise)
Sr.
No. |
Material
Code |
Material Name | Spec. | Function | Unit | Qty./ unit dose | Overages (%) | Qty./Batch |
Stage A | ||||||||
Stage B | ||||||||
Calculation sheet (Where Required): | ||||||||
Remark/s: |
Note:
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- In the case of Coated Tablets, a separate Bill of Material (BOM) shall be given for core and coated tablets.
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- A calculation sheet for potency calculation of active ingredients is to be provided, wherever applicable.
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List of Equipment & Instruments
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Sr.
No. |
Equipment/Instrument | ID No. | Operating capacity | Ref SOP No. |
1. |
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- Environmental Conditions
Sr. No. | Hold & Processing Area | Temperature (°C) | RH (%) | |
1. |
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- Special Precautions
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- Define precautions to be taken while compounding this formulation which may be related to proper gowning, adequate environment conditions, and or practices to be followed while compounding.
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- Manufacturing Methodology
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- Receipt & verification of materials.
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- Precautions
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- This section describes any precautions to be taken during the manufacturing of the product.
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- Shall specify the various checkpoints like environmental conditions, etc. that shall be taken care of before starting and during the manufacturing process.
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- Reference of standard operating procedures if any shall be specified.
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Manufacturing process
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- Detailed stepwise processing instructions and the time taken for each step;
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- Instructions for in-process controls with their limits;
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- The requirements for storage conditions of the products, including the container, labeling, and special storage conditions where applicable;
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- Any special precautions to be observed;
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- A statement of the expected final yield with the acceptable limits (Min.& Max.) and of relevant intermediate yields, where applicable.
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- In-process Testing and Release
Sr. No. | Manufacturing Stage | Parameter | Acceptance criteria | |
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- Recovery Procedure
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- The addition of recovery in batch shall be handled as per respective SOP.
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- Specification of Raw Materials
Specifications- Raw Materials | |||
Sr. No. | Material Code | Material Name | Specification No. |
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- Specification of Packing materials (Sale/PS)
Specifications- Packing Material | |||
A. Sales | |||
Sr. No. | Material Code | Material Name | Specification No. |
B. Physician Samples | |||
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Packing instructions
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- General Instructions
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- All the activities should be carried out at ____ºC & _____0% Relative Humidity.
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- Equipment and Product containers should be properly labeled at all stages during the packing.
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- Clean the equipment after use as per the standard operating procedures.
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- Take only inspected and approved products for packing from the manufacturing section along with batch records.
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- Ensure that product containers are counter-checked by Quality Assurance for Product Name, Batch no., Batch Size, No. of containers, and weight in kg.
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- Approved packaging materials issued by the store should be used for packing.
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- During the packaging process cover the hoppers of the strip-packaging machine with lids.
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- Destroy the Batch over-printing Stereos after completion of the batch by cutting it into four pieces.
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- Batch Packing Material
Sr.
No. |
Material Code | Material Name | Overages (%) | Qty./Batch | Unit |
Sales | |||||
1. | |||||
Physician Samples(PS) | |||||
2. |
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- List of Equipment & Instruments
Sr.
No. |
Equipment/Instrument | ID No. | Operating capacity | Ref SOP No. |
1. |
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- Over Printing Instructions
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- The procedure to be followed during over-printing/coding shall be defined here.
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- Packing Instructions
Instruction for packing, specific to this product shall be briefly defined here.
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- Packing Material Reconciliation
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- Reconciliation of each packing material shall be for the total used quantity.
- Batch Yield Reconciliation
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- Stage-wise Yield reconciliation shall be carried out.
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- Expected Yield is NLT______% and NMT_________%
Format No. 05: Template for Preparation of Primary Packing Material & Raw Material BOM (Injections)
QUALITY ASSURANCE DEPARTMENT |
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BILL OF MATERIAL – PRIMARY PACKING MATERIAL & RAW MATERIAL |
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Generic Name | ||||||||||||
Product Name | ||||||||||||
Market | BOM No. | Supersedes | ||||||||||
Product Code (Semi finished) | MFR No. | Supersedes | ||||||||||
Batch Size (In kg)
(Approximate Vials)* |
Shelf Life | Page No. | ||||||||||
S. No. | Material Code | Material Name | Spec. | Qty./Unit (mg) | Overages (%) | Qty./ Batch | Unit | |||||
Primary Packing Materials : | ||||||||||||
Raw Materials : | ||||||||||||
Remark/s:
Batch Size = Qty. of Raw Material X 1000 X 1000 Fill Weight per Vial Note: * Batch size in vials and fill weight will vary as per potency of Raw Material. |
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Reason for Issue/Revision : |
Format No. 06: Template for Preparation of Packing Material BOM (Injections)
QUALITY ASSURANCE DEPARTMENT |
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BILL OF MATERIAL – PACKING MATERIAL |
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Generic Name | ||||||||||||
Product Name | ||||||||||||
Market | BOM No. | Supersedes | ||||||||||
Product Code (Finished Goods) | MFR No. | Supersedes | ||||||||||
Batch Size (In kg)
(Approximate Vials)* |
Shelf Life | Page No. | ||||||||||
S. No. | Material Code | Material Name | Spec. | Qty./Unit (mg) | Overages | Qty./ Batch | Unit | |||||
Secondary Packing Materials : | ||||||||||||
Tertiary Packing Materials : | ||||||||||||
Note: * Batch size in vials and fill weight will vary as per potency of Raw Material. | ||||||||||||
Reason for Issue/Revision : |
Format No. 07: List of MFR & BOM
Sr. No. | Generic Name | Product Name | Batch Size | MFR No. | Bill of Materials | Remarks | |
Raw materials | Pacing Materials | ||||||
Annexure – I: Guidance for Master Formula Record (MFR) Preparation.
Contents of Manufacturing Master Formula |
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WHO TRS 908 Annex 4 section 15.23 | EU GMP Guideline (Jan 06) Section 4.14 and 4.15 | PICs document PE099 (Jan 06) section 4.14 and 4.15 | Health Canada GMP Guideline Version 2 (2002), section 24. |
The master formula should include |
The Manufacturing Formula/Processing Instructions should include | The Manufacturing Formula/Processing Instructions should include | Master Manufacturing Formula: Master formulas are written to provide not less than 100% of label claim and include the following |
Name of the product, with a product reference code relating to its specification |
The name of the product, with a product reference code relating to its specification | The name of the product, with a product reference code relating to its specification | The name of the product, with a reference code relating to its specifications |
A description of the dosage form, strength of the product, and batch size |
A description of the pharmaceutical form, strength of the product, and batch size | A description of the pharmaceutical form, strength of the product, and batch size | A description of the dosage form, strength of the product, and batch size |
A list of all starting materials to be used (if applicable, with the INNs), with the amount of each, described using the designated name and a reference that is unique to that material (mention should be made of any substance that may disappear in the course of processing) |
A list of all starting materials to be used, with the amount of each, described using the designated name and a reference that is unique to that material; mention should be made of any substance that may disappear in the course of processing | A list of all starting materials to be used, with the amount of each, described using the designated name and a reference that is unique to that material; mention should be made of any substance that may disappear in the course of processing | A list of all raw materials to be used, along with the amount of each, described using the designated name and a reference that is unique to that material (mention is made of any processing aids that may not be present in the final product) |
A statement of the expected final yield with the acceptable limits, and of relevant intermediate yields, where applicable |
A statement of the expected final yield with the acceptable limits, and of relevant intermediate yields, where applicable | A statement of the expected final yield with the acceptable limits, and of relevant intermediate yields, where applicable | A statement of the expected final yield, along with the acceptable limits, and of relevant intermediate yields, where applicable |
A statement of the processing location and the principal equipment to be used |
A statement of the processing location and the principal equipment to be used | A statement of the processing location and the principal equipment to be used | A statement of the principal equipment to be used |
The methods, or reference to the methods, to be used for preparing and operating the critical equipment, e.g. cleaning (especially after a change in product), assembling, calibrating, sterilizing, use | The methods, or reference to the methods, to be used for preparing the critical equipment (e.g. cleaning, assembling, calibrating, sterilizing) | The methods, or reference to the methods, to be used for preparing the critical equipment (e.g. cleaning, assembling, calibrating, sterilizing)
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The procedures, or reference to the procedures, to be used for preparing the critical equipment, e.g., cleaning (especially after a change in product), assembling, calibrating, sterilizing, etc
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Detailed step-wise processing instructions (e.g. checks on materials, pretreatments, sequence for adding materials, mixing times, temperatures) | Detailed stepwise processing instructions (e.g. checks on materials, pre-treatments, sequence for adding materials, mixing times, temperatures) | Detailed stepwise processing instructions (e.g. checks on materials, pretreatments, sequence for adding materials, mixing times, temperatures) | Detailed stepwise processing instructions (e.g., checks on materials, pretreatment, sequence for adding materials, mixing times or temperatures, etc.) |
The instructions for any in-process controls with their limits |
The instructions for any in-process controls with their limits | The instructions for any in-process controls with their limits | The instructions for any in-process controls, along with their limits |
Where necessary, the requirements for storage of the products, including the container, the labeling, and any special storage conditions | Where necessary, the requirements for bulk storage of the products; including the container, labeling, and special storage conditions where applicable | Where necessary, the requirements for bulk storage of the products; including the container, labeling, and special storage conditions where applicable | Where necessary, the requirements for storage of the products, including the container, the labeling, and any special storage conditions |
Any special precautions to be observed | Any special precautions to be observed | Any special precautions to be observed | Any special precautions to be observed |
Contents of Packaging Master Formula |
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WHO TRS 908 Annex 4 (2003) Section 15.24 | EU GMP Guideline (Jan 06) Sections 4.16 | PICs document PE099 (Jan 06) Sections 4.16 | Health Canada GMP Guideline Version 2 (2002), section 25 |
Formally authorized packaging instructions should exist for each product, pack size and type. These should normally include, or refer to: | There should be formally authorized Packaging Instructions for each product, pack size and type. These should normally include, or have a reference to, the following | There should be formally authorized Packaging Instructions for each product for pack size and type. These should normally include, or have a reference to, the following: | In the case of a packaged product, the master formula also includes for each product, package size and type, the following:
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The name of the product; |
a) Name of the product | Name of the product; | |
A description of its pharmaceutical form, strength and, where applicable, method of application; | b) Description of its pharmaceutical form, and strength where applicable; | Description of its pharmaceutical form, and strength where applicable; | |
The pack size is expressed in terms of the number, weight or volume of the product in the final container |
c) The pack size expressed in terms of the number, weight or volume of the product in the final container | The pack size is expressed in terms of the number, weight or volume of the product in the final container | The package size, expressed in terms of the number, weight, or volume of the product in the final container |
A complete list of all the packaging materials required for a standard batch size, including quantities, sizes, and types, with the code or reference number relating to the specifications for each packaging material | d) A complete list of all the packaging materials required for a standard batch size, including quantities, sizes, and types, with the code or reference number relating to the specifications of each packaging material | A complete list of all the packaging materials required for a standard batch size, including quantities, sizes, and types, with the code or reference number relating to the specifications of each packaging material | A complete list of all the packaging materials required for a standard batch size, including quantities, sizes, and types with the code or reference number relating to the specifications for each packaging material |
Where appropriate, an example or reproduction of the relevant printed packaging materials and specimens, indicating where the batch number and expiry date of the product have been marked |
e) Where appropriate, an example or reproduction of the relevant printed packaging materials, and specimens indicating where to apply batch number references and shelf life of the product
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Where appropriate, an example or reproduction of the relevant printed packaging materials, and specimens indicating where to apply batch number references and shelf-life of the product
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An example or reproduction of the relevant printed packaging materials and specimens, indicating where the batch number and expiry date of the product are to be positioned
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Special precautions are to be observed, including a careful examination of the packaging area and equipment in order to ascertain the line clearance before and after packaging operations | f) Special precautions to be observed, including a careful examination of the area and equipment to ascertain the line clearance before operations begin | Special precautions are to be observed, including a careful examination of the area and equipment in order to ascertain the line clearance before operations begin | Special precautions are to be observed, including a careful examination of the packaging area and equipment to ascertain the line clearance before operations begin |
A description of the packaging operation, including any significant subsidiary operations, and equipment to be used |
g) A description of the packaging operation, including any significant subsidiary operations, and equipment to be used | A description of the packaging operation, including any significant subsidiary operations, and equipment to be used | A description of the packaging operations, including any significant subsidiary operations and the equipment to be used |
Details of in-process controls with instructions for sampling and acceptance limits | h) Details of in-process controls with instructions for sampling and acceptance limits | Details of in-process controls with instructions for sampling and acceptance limits | Details of in-process controls, with instructions for sampling and acceptance limits |
USA 21 CFR 211:186 |
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Master production and control records shall include: | |||
The name and strength of the product and a description of the dosage form | |||
The name and weight or measure of each active ingredient per dosage unit or per unit of weight or measure of the drug product, and a statement of the total weight or measure of any dosage unit | |||
A complete list of components designated by names or codes sufficiently specific to indicate any special quality characteristic | |||
An accurate statement of the weight or measure of each component, using the same weight system (metric, avoirdupois, or apothecary) for each component. Reasonable variations may be permitted, however, in the amount of components necessary for the preparation in the dosage form, provided they are justified in the master production and control records | |||
A statement concerning any calculated excess of component |
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A statement of theoretical weight or measure at appropriate phases of processing | |||
theoretical yield, including the maximum and minimum percentages of theoretical yield beyond which investigation according to 211.192 is required | |||
A statement of theoretical yield, including the maximum and minimum percentages of theoretical yield beyond which investigation according to 211.192 is required | |||
Complete manufacturing and control instructions, sampling and testing procedures, specifications, special notations, and precautions to be followed | |||
SCHEDULE M PART I GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS: MAIN PRINCIPLES | |||
Master Formula Records – |
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A formally authorized master formula shall exist for each product and batch size to be manufactured. | |||
The master formula records shall include the following, namely:- | |||
(a) the name of the product, with a product reference code relating to its specification; | |||
(b) a description of the dosage form, strength of the product, and batch size; | |||
(c) a list of all starting materials to be used (if applicable with the INNs), with the amount of each, described using the designated name and a reference that is unique to that material (mention shall be made of any substance that may disappear in the course of processing); | |||
(d) a statement of the expected final yield with the acceptable limits and of relevant intermediate yields, where applicable; | |||
(e) a statement of the processing location and the principal equipment to be used; |
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(f) the methods or reference to the methods to be used for preparing and operating the critical equipment, e.g., cleaning (especially after a change in product), assembling, calibrating, sterilizing, use; | |||
(g) detailed step-wise processing instructions (e.g., checks on materials, pretreatments, sequence for adding materials, mixing times and temperatures); | |||
(h) the instructions for any in-process controls with their limits; | |||
(i) Where necessary, the requirements for storage of the products, including the container, the labeling and any special storage conditions; | |||
(j) any special precautions to be observed; and | |||
(k) the hold time permitted for intermediate and in-process material. | |||
Packaging instructions-Formally authorized packaging instructions shall exist for each product, pack size, and type. These shall normally include or make reference to the following, namely:— |
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(a) the name of the product; | |||
(b) a description of its pharmaceutical form, strength and, where applicable, method of application; | |||
(c) the pack size expressed in terms of the number, weight or volume of the product in the final container; | |||
(d) a complete list of all the packaging materials required for a standard batch size, including quantities, sizes, and types, with the code or reference number relating to the specifications for each packaging material; | |||
(e) where appropriate, an example or reproduction of the relevant printed packaging materials and specimens, indicating where the batch number and expiry date of the product have been marked; | |||
(f) special precautions to be observed, including a careful examination of the packaging area and equipment to ascertain the line clearance before and after packaging operations; | |||
(g) a description of the packaging operation, including any significant subsidiary operations, and equipment to be used; and | |||
(h) details of in-process controls with instructions for sampling and acceptance limits. |