Industrial Hygiene – SOP & Guideline
The Standard Operating Procedure (SOP) to describe the various aspect of Industrial Hygiene in pharmaceutical drug manufacturing plants. Industrial Hygiene – The science devoted to the anticipation, recognition, evaluation, prevention, and control of those occupational factors or stresses arising in or from the workplace which may cause sickness, impaired health and well being, or significant […]
Physical & Logical Control Policy of Computer System
Standard Operating Procedure (SOP) for Physical and Logical Control Policy of Computer system to fulfill the requirement of 21CFR Part 11 under the cGMP activity in the pharmaceutical drug manufacturing unit. Computer System Control Policy 1.0 Purpose: To define the process of the physical and logical security policy of the computer system. 2.0 Scope: This […]
Entry and Exit Procedure in QC Laboratory
Standard Operating Procedure (SOP) for Entry and Exit Procedure in Quality Control (QC) Laboratory in a pharmaceutical plant. Entry and Exit Procedure in QC Lab 1.0 PURPOSE: The purpose of this SOP is to laydown the entry and exit procedure for Quality Control (QC) Laboratory area. 2.0 SCOPE: This procedure shall be applicable to the […]
Operation Procedure of 1010 KVA DG Set
Standard Operating Procedure (SOP) for the operation of 1010 KVA Diesel Generating – DG Set installed for power backup in the pharmaceutical drug manufacturing plant. Procedure for Operating of 1010 KVA DG Set 1.0 PURPOSE: The purpose of this SOP is to define the procedure for the operation of the 1010 KVA DG set. 2.0 […]
Raw Material Reconciliation SOP
Standard Operating Procedure (SOP) for Raw Material Reconciliation in the warehouse/store department in pharmaceuticals to maintain the stock of raw material. Procedure for Raw Material Reconciliation 1.0 PURPOSE: The purpose of this SOP is to define the procedure for raw material reconciliation. 2.0 SCOPE: This procedure is applicable to all raw materials for verification of […]
Purified Water – Sampling and Testing Procedure
Standard Operating Procedure (SOP) for sampling from different points and microbiological analysis/testing of Purified water samples in pharmaceutical plants. Sampling and Testing of Purified Water in Microbiology 1.0 PURPOSE: To lay down the procedure for Sampling and Testing of Purified Water. 2.0 SCOPE: This Standard Operating Procedure is applicable to the Microbiology Department. 3.0 REFERENCE: […]
Analyst Qualification SOP in Quality Control
Standard Operating Procedure (SOP) for Analyst/Chemist Qualification, Data Reviewer Qualification through performing parallel Analysis, and other evaluation parameters. Procedure of Analyst / Reviewer Qualification 1.0 PURPOSE: The purpose of this SOP is to describe the procedure for analyst/reviewer qualification. 2.0 SCOPE: The SOP is applicable for analyst/reviewer qualification in the Quality Control department at the […]
Waters HPLC System-Operation SOP with Empower
Standard Operating System (SOP) for Operation of Waters High-Performance Liquid Chromatography (HPLC) system. This procedure applies to the Waters – Alliance HPLC system. SOP for Waters HPLC System 1.0 Purpose : This SOP is to describe the operation procedure of the High-Performance Liquid Chromatographic (HPLC) system (Make-Waters, Model-Alliance) in the Quality Control Department. 2.0 Scope: […]
Master Batch Record (MBR) – SOP
Standard Operating Procedure (SOP) for preparation, review, approval, issuance, maintenance, and archival of controlled Master Batch Record (MBR) throughout the product lifecycle to meet and maintain sustainable compliance to current Good Manufacturing Practices (cGMPs). SOP for Master Batch Record (MBR) 1.0 PURPOSE: The purpose of this procedure is to establish uniform requirements and guidelines utilizing […]
Inspection and Handling of Sieves and Screens
Standard Operating Practices (SOP) for the receipt, checking, passivation, storage, and disposal (handling) of Sieves/Screens. Procedure for Handling of Sieves and Screens 1.0 PURPOSE: The purpose of this SOP is to lay down the procedure for inspection & handling of Sieves and Screens. 2.0 SCOPE: This SOP is applicable to the receipt, checking, numbering, passivation, […]
Drug Product Packing – Guideline and SOP
Standard Operating Procedure (SOP/Guideline) for Packing of Drug Product. General rules to be adopted in the packing section for maintaining product identity, eliminating the potential mix-ups, handling of rejection, and smooth operation of the packing department. Guideline for Drug Product Packing 1.0 PURPOSE: The purpose of this SOP is to lay down general rules (to […]
Entry and Exit Procedure in Primary Area
Standard Operating Procedure (SOP) for Entry and Exit in the primary area of production at the pharmaceutical drug manufacturing plant. Procedure for Entry and Exit in the Primary Area 1.0 PURPOSE: The purpose of this SOP is to laydown the entry and exit procedure in the Primary Area of the production department at the pharmaceutical […]
Polarimeter – Operation, Cleaning, Calibration SOP
Standard Operating Procedure (SOP) for Operation, Calibration, Cleaning and general maintenance of Jasco make Polarimeter instrument. Procedure for Operation, Calibration, and Cleaning of Polarimeter 1.0 Purpose: The purpose of this SOP is to describe the procedure for operation, cleaning, and calibration of the polarimeter. 2.0 Scope: This SOP is applicable to the polarimeter available in […]
Neocota Coating Machine : Operation/Cleaning SOP
Standard Operating Procedure (SOP) for Operation and Cleaning of Neocota Coating Machine 48’’ & 60’’ used in the coating process. SOP for Neocota Coating Machine 1.0 Purpose: The purpose of this SOP is to describe the procedure for efficient cleaning & operation of Neocota 48’’ & 60’’ in the coating process. 2.0 Scope: This SOP […]
Conductivity Meter – SOP for Operation,Calibration
Standard Operating Procedure (SOP) for Operation, Calibration, and Cleaning of the Conductivity meter. Conductivity is the ability of a solution to conduct electricity and the electricity is conducted in solution by ions present unit of measurement of conductivity is Siemen (S). Procedure for Operation and Calibration of Conductivity Meter 1.0 PURPOSE: The purpose of this […]
Process Standardization and Validation – SOP
Standard Operating Procedure (SOP) for Process Standardization and Validation be carried for the new products and existing products at the formulation plant. SOP for Process Standardization and Validation 1.0 Purpose: To lay down a procedure for process standardization and process validation study. 2.0 Scope – Process Standardization and Validation: The SOP is applicable to process […]
Batch Release Procedure of Finished Product
Standard Operating Procedure (SOP) for approval and release of Finished Product Batch for moving from the manufacturing site to supply chain/distributors or C&F warehouses. Procedure for Finished Product Batch Release 1.0 PURPOSE: To lay down the procedure for approval and release of the finished product batch. 2.0 SCOPE: This Standard Operating Procedure is applicable for […]
Cleaning Validation (CV) Procedure – SOP
Standard Operating Procedure (SOP) for Cleaning Validation (CV) in the pharmaceutical drug manufacturing plants. Cleaning Validation (CV) is the documented evidence that an approved cleaning procedure is consistent in reducing product residue and removal of cleaning agents (if any), bioburden, flavor (if any), color (if any) from equipment and accessories within the acceptance level. Procedure […]
Handling Power Failure Situation (SOP) in Plant
Standard Operating Procedure (SOP) for Handling Power Failure situations in different areas like Production, Quality Contro, Microbiology, Utility, Stores, etc at the pharmaceutical drug manufacturing plant. Procedure for Handling of Power Failure in Pharma 1.0 Purpose: To lay down a procedure for handling power failure situations. 2.0 Scope: This procedure is applicable to handling power […]
Media Fill Validation – SOP for Process Simulation
Standard Operating Procedure (SOP) for Media Fill Validation in Sterile facility. A “media fill” (sometimes known as a “process simulation”) is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium in place of the drug solution. The microbiological growth medium is used in place of the drug solution during media fills […]
Good Chromatography Practices – SOP & Guideline
Chromatography is a laboratory technique for the separation of a mixture. The mixture is dissolved in a fluid called the mobile phase, which carries it through a structure holding another material called the stationary phase. The various constituents of the mixture travel at different speeds, causing them to separate. GOOD CHROMATOGRAPHY PRACTICES 1.0 PURPOSE : The […]
HVAC System Qualification Protocol (Validation)
Protocol for Qualification and Re-Qualification or Validation of Heating Ventilation and Air Conditioning (HVAC) system for Clean Room. HVAC System Qualification Protocol (Validation) Table of Content – HVAC System Qualification Protocol S.No. Table of Contents Page 1.0 Protocol Approval 2.0 History Sheet 3.0 Objective 4.0 Scope 5.0 Responsibilities 6.0 Equipment Description 6.1 System Specification […]
HVAC System : SOP for Qualification
Standard Operating System (SOP) for Qualification and Re-Qualification of Heating Ventilation and Air Conditioning (HVAC) system for Clean Room. Qualification of HVAC System 1.0 PURPOSE The Purpose of this SOP is to lay down the Procedure for qualification/Requalification, of Heating Ventilation and Air Conditioning System (HVAC). 2.0 SCOPE This SOP is applicable for the qualification/requalification […]
Pharmacopoeial Change Management SOP
Standard Operating Procedure (SOP) for the handling of Pharmacopoeial Change at Drug Product Manufacturing Location. Handling when Pharmacopoeial changes in monographs and appearance of the new monographs for drug substances, excipients, drug products and updation or addition or deletion of general chapters. Handling of Pharmacopoeial Change at Drug Manufacturing Location 1.0 Purpose: To define the […]
Dissolution Apparatus – Operation & Calibration SOP
Standard Operating Procedure (SOP) for Operation and Calibration of Dissolution Test Apparatus (Make- Electrolab) used to measure the drug release of Oral Solid Doses in pharmaceuticals. This SOP Contains following Topics – A) Operating Procedure for Electrolab Dissolution Apparatus, Model : TDT-08L 0, TDT-14L, and similar models. B) Calibration Procedure and Formats for Dissolution Apparatus […]
Melting Point Apparatus – SOP
Standard Operating Procedure (SOP) for Operation and Calibration of Melting Point Apparatus used for analysis / identification of starting materials (Raw Material – API & Excipient) in Quality Control Laboratory. Operation and Calibration of Melting Point Apparatus 1.0 PURPOSE: The purpose of this SOP is to describe the procedure for operation, calibration and maintenance of […]
Laboratory Oven – SOP for Operation & Maintenance
Standard Operating Procedure (SOP) for operation and maintenance of Laboratory Oven used for glassware dying or Loss on Drying etc. in quality control laboratory. SOP for Laboratory Oven 1.0 PURPOSE: The purpose of this SOP is to describe the procedure for the operation and maintenance of a laboratory oven. 2.0 SCOPE: This SOP is applicable […]
Process Standardization and Validation – SOP
Standard Operating Procedure (SOP) for Process Standardization and Validation be carried for the new products and existing products at the formulation plant. SOP for Process Standardization and Validation 1.0 Purpose: To lay down a procedure for process standardization and process validation study. 2.0 Scope – Process Standardization and Validation: The SOP is applicable to process […]
Batch Release Procedure of Finished Product
Standard Operating Procedure (SOP) for approval and release of Finished Product Batch for moving from the manufacturing site to supply chain/distributors or C&F warehouses. Procedure for Finished Product Batch Release 1.0 PURPOSE: To lay down the procedure for approval and release of the finished product batch. 2.0 SCOPE: This Standard Operating Procedure is applicable for […]
Cleaning Validation (CV) Procedure – SOP
Standard Operating Procedure (SOP) for Cleaning Validation (CV) in the pharmaceutical drug manufacturing plants. Cleaning Validation (CV) is the documented evidence that an approved cleaning procedure is consistent in reducing product residue and removal of cleaning agents (if any), bioburden, flavor (if any), color (if any) from equipment and accessories within the acceptance level. Procedure […]
Handling Power Failure Situation (SOP) in Plant
Standard Operating Procedure (SOP) for Handling Power Failure situations in different areas like Production, Quality Contro, Microbiology, Utility, Stores, etc at the pharmaceutical drug manufacturing plant. Procedure for Handling of Power Failure in Pharma 1.0 Purpose: To lay down a procedure for handling power failure situations. 2.0 Scope: This procedure is applicable to handling power […]
Media Fill Validation – SOP for Process Simulation
Standard Operating Procedure (SOP) for Media Fill Validation in Sterile facility. A “media fill” (sometimes known as a “process simulation”) is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium in place of the drug solution. The microbiological growth medium is used in place of the drug solution during media fills […]
Good Chromatography Practices – SOP & Guideline
Chromatography is a laboratory technique for the separation of a mixture. The mixture is dissolved in a fluid called the mobile phase, which carries it through a structure holding another material called the stationary phase. The various constituents of the mixture travel at different speeds, causing them to separate. GOOD CHROMATOGRAPHY PRACTICES 1.0 PURPOSE : The […]
HVAC System Qualification Protocol (Validation)
Protocol for Qualification and Re-Qualification or Validation of Heating Ventilation and Air Conditioning (HVAC) system for Clean Room. HVAC System Qualification Protocol (Validation) Table of Content – HVAC System Qualification Protocol S.No. Table of Contents Page 1.0 Protocol Approval 2.0 History Sheet 3.0 Objective 4.0 Scope 5.0 Responsibilities 6.0 Equipment Description 6.1 System Specification […]
HVAC System : SOP for Qualification
Standard Operating System (SOP) for Qualification and Re-Qualification of Heating Ventilation and Air Conditioning (HVAC) system for Clean Room. Qualification of HVAC System 1.0 PURPOSE The Purpose of this SOP is to lay down the Procedure for qualification/Requalification, of Heating Ventilation and Air Conditioning System (HVAC). 2.0 SCOPE This SOP is applicable for the qualification/requalification […]
Pharmacopoeial Change Management SOP
Standard Operating Procedure (SOP) for the handling of Pharmacopoeial Change at Drug Product Manufacturing Location. Handling when Pharmacopoeial changes in monographs and appearance of the new monographs for drug substances, excipients, drug products and updation or addition or deletion of general chapters. Handling of Pharmacopoeial Change at Drug Manufacturing Location 1.0 Purpose: To define the […]
Dissolution Apparatus – Operation & Calibration SOP
Standard Operating Procedure (SOP) for Operation and Calibration of Dissolution Test Apparatus (Make- Electrolab) used to measure the drug release of Oral Solid Doses in pharmaceuticals. This SOP Contains following Topics – A) Operating Procedure for Electrolab Dissolution Apparatus, Model : TDT-08L 0, TDT-14L, and similar models. B) Calibration Procedure and Formats for Dissolution Apparatus […]
Melting Point Apparatus – SOP
Standard Operating Procedure (SOP) for Operation and Calibration of Melting Point Apparatus used for analysis / identification of starting materials (Raw Material – API & Excipient) in Quality Control Laboratory. Operation and Calibration of Melting Point Apparatus 1.0 PURPOSE: The purpose of this SOP is to describe the procedure for operation, calibration and maintenance of […]
Laboratory Oven – SOP for Operation & Maintenance
Standard Operating Procedure (SOP) for operation and maintenance of Laboratory Oven used for glassware dying or Loss on Drying etc. in quality control laboratory. SOP for Laboratory Oven 1.0 PURPOSE: The purpose of this SOP is to describe the procedure for the operation and maintenance of a laboratory oven. 2.0 SCOPE: This SOP is applicable […]
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