SOP For Handling of Laboratory Incident
SOP for handling and reporting of Laboratory Incident (Lab Event ) occurs in the Quality Control like be-Bracketing standard failure, Improper peak shape, Extraneous peak, baseline disturbance, peak elution pattern change, Data missing, wrong standard/sample weight taken, wrong standard/sample preparation, wrong wavelength selection, wrong analytical column selection, etc. SOP for Handling and Reporting of Laboratory […]
SOP for Review of Analytical Report and Raw Data
Standard Operating Procedure (SOP) for Review of Analytical Report and Raw Data. Analytical raw data is data generated during sample analysis and includes traceability of equipment and reagents used for analysis e.g. name of the material, instrument ID, template, chromatograms (Electronic and hard copy), the potency of reference standard / working standard /reagent, calculations, results, […]
SOP for Issuance of Packing Material
Standard Operating Procedure for Issuance / Dispensing of Packaging Material (Packing Materials) like Corrugated box, Primary Packaging Material (PPM), Secondary Packing Material, Aluminum Foils, BOPP tape, PVC Foils, etc. which is required to pack the drug product. Procedure for Packing Material Dispensing / Issuance 1.0 PURPOSE: The purpose of this SOP is to […]
Operation and Calibration of pH Meter
Standard Operating Procedure (SOP) for Operation, standardization, calibration, and maintenance of pH meter including pH meter electrode care. SOP for Operation and Calibration of pH Meter 1.0 PURPOSE: The purpose of this SOP (Standard Operating Procedure) is to describe the procedure of operation, standardization, and maintenance of pH meter. 2.0 SCOPE: […]
SOP for Handling of Laboratory Reagents
Standard Operating Procedure (SOP) for Receipt, Storage, and Handling of Laboratory Reagents, Buffers, Solvents, Glasswares and other consumables in QC. Receipt, Storage, and Handling of Laboratory Reagents 1.0 Purpose : The purpose of this SOP ( Standard Operating Procedure) is to describe the procedure for the receipt, storage, and handling of laboratory reagents. […]
SOP for Handling of Out of Calibration (OOC)
Standard Operating Procedure for Handling of Out of Calibration (OOC) for Laboratory Instrument and Equipment. The result which does not meet the pre-established acceptance criteria for the instrument calibration shall be termed as Out of Calibration (OOC). SOP for Handling of Out of Calibration (OOC) Results 1.0 PURPOSE The purpose of this Standard […]
SOP for Internal and External Calibration of Instrument
Standard Operating Procedure for Laboratory Instrument and Equipment calibration through Internal or External (Third Party). This SOP includes the calibration procedure, schedule/planner and frequency of Instrument calibration in quality control laboratory. SOP for Laboratory Instrument Calibration 1.0 Purpose: The purpose of this SOP ( Standard Operating Procedure) is to describe the procedure for […]
Checklist for Review of Microbiology Data
Checklist for review of microbiology data generated during the different tests of microbiology i.e. Antibiotic Assays, Particulate matter test, BET test, Preservative effectiveness testing ( Antimicrobial effectiveness testing), Microbial limit test (MLT), sterility, water analysis, and preservative effectiveness testing, Sterility testing. etc. Checklist for Microbiological Analytical Data and Reports Followings are the checkpoints during the […]
Acceptable Quality Level (AQL) – SOP and Chart
The Acceptable Quality Level (AQL) is a percent defective that is the baseline requirement for the quality of the producer’s product. The producer would like to design a sampling plan such that there is a high probability of accepting a lot that has a defect level less than or equal to the AQL. SOP for […]
Checklist for Review of Analytical Raw Data (Chemical)
Checklist for review of analytical raw data generated during the chemical analysis of finished drug product, the raw material (API-Active Pharmaceutical Ingredient / Excipient), Inprocess samples and stability study sample analysis. Checklist for Review of Analytical Raw Data (Test wise) 1.0 Product Information (Review of Raw Data / Report) : Name of material […]
Stability Study SOP as per ICH Guideline
Stability study sop prepared according to ICH guidelines with required stability study sample incubation, sample pullouts and analysis of samples and summary. SOP for Stability Study of Drug Product 1.0 Purpose: The purpose of this SOP is to describe the procedure for sample collection, selection of batches, incubation, withdrawal, analysis, reporting, and evaluation, […]
SOP for Operation and Calibration of UV Cabinet
Standard Operating Procedure for Operation and calibration of UV cabinet for reviewing the TLC plate, Photolytic Degradation, UV cabinet Performance check. SOP for UV Cabinet (Operation & Calibration) 1.0 PURPOSE: The purpose of this Standard Operating Procedure ( SOP ) is to describe the procedure for suitability of the emission intensity of the […]
SOP for Audit Trail Review and Privilege Policy
In the Quality Control Laboratory of the pharmaceutical product manufacturing unit, Different instruments, and equipment being used to analyze the drug product. the documented tracking or list of activities known as the Audit trail. An audit trail can be either a paper or electronically based trail that provides a documented history of a transaction within […]
Isolation and Identification of Microorganisms
Standard Operating Procedure (SOP) for Isolation and Identification of Microorganisms (Microbes). Isolation and Identification of Microorganisms 1.0 PURPOSE: To lay down the Procedure for Isolation and Identification of Microorganisms. 2.0 SCOPE: This Standard Operating Procedure is applicable to the Microbiology Department at the pharmaceutical manufacturing unit. 3.0 REFERENCE: SOP for […]
SOP for Quality Risk Management (Guideline ICH Q9)
Quality Risk Management: An overall and continuing systematic process for the assessment, control, communication and review of risks to the quality of a pharmaceutical product or medical device across the product lifecycle in order to optimize its benefit-risk balance. SOP for Quality Risk Management 1.0 PURPOSE: This Standard Operating Procedure (SOP) establishes uniform […]
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 […]
Handling of Hold Time Drug Samples
Standard Operating Procedure (SOP) to establish the hold time of drug samples at the different stages of manufacturing (like starting material/Raw material, Intermediate and bulk product) prior to the final packing of the drug. Procedure to Establish the Hold Time of Samples Visit to copy this SOP 1.0 PURPOSE: The purpose of this SOP is […]
Compression Machine : Operation and Cleaning SOP
Standard Operating Procedure (SOP) for Cleaning and Operation Procedure for double rotary Tablet Compression Machine (45 And 55 Station). Operation and Cleaning Procedure of Tablet Compression Machine 1.0 PURPOSE: To lay down the efficient cleaning and operation of Double rotary compression machine Cadpress 45/55 stations Mark IV. 2.0 SCOPE: This procedure is applicable for the […]
SOP for Workplace During COVID-19 (Corona Virus)
Standard Operating Procedure (SOP) of Workplace instructions pertaining to health protocol during COVID-19 (Corona Virus) pandemic to be complied with by the pharmaceutical drug manufacturing plant. Health Protocol at the Workplace (Pharma) during COVID-19 (Corona Virus) 1.0 PURPOSE The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for health safety […]
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 […]
Handling of Hold Time Drug Samples
Standard Operating Procedure (SOP) to establish the hold time of drug samples at the different stages of manufacturing (like starting material/Raw material, Intermediate and bulk product) prior to the final packing of the drug. Procedure to Establish the Hold Time of Samples Visit to copy this SOP 1.0 PURPOSE: The purpose of this SOP is […]
Compression Machine : Operation and Cleaning SOP
Standard Operating Procedure (SOP) for Cleaning and Operation Procedure for double rotary Tablet Compression Machine (45 And 55 Station). Operation and Cleaning Procedure of Tablet Compression Machine 1.0 PURPOSE: To lay down the efficient cleaning and operation of Double rotary compression machine Cadpress 45/55 stations Mark IV. 2.0 SCOPE: This procedure is applicable for the […]
SOP for Workplace During COVID-19 (Corona Virus)
Standard Operating Procedure (SOP) of Workplace instructions pertaining to health protocol during COVID-19 (Corona Virus) pandemic to be complied with by the pharmaceutical drug manufacturing plant. Health Protocol at the Workplace (Pharma) during COVID-19 (Corona Virus) 1.0 PURPOSE The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for health safety […]
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