Cleaning Validation Protocol Format -CV
A cleaning validation protocol format shall be developed for the ‘worst case’ product selected for cleaning validation programme. Following information (but not limited to) the following included in the cleaning validation protocol. Numbering of protocol shall done through of respective SOP of Cleaning Validation Protocol Numbering. Cleaning Validation Protocol Format – Objective: A brief description […]
Cleaning Validation master plan (CVMP)-New Approach
Introduction: Cleaning validation Master Plan will function as an umbrella guidance document for all the cleaning validation protocols, programs, and procedures adopted to ensure that all the equipment utilized for the manufacturing of tablets and hard gelatin capsules dosage form are cleaned up an acceptable level. The Pharmaceuticals manufacturing entities which engaged in manufacturing of […]
HPLC Calibration -A complete Guide -Part 3 of 3
A Complete Guide on HPLC Calibration – Part 3 of 3 (Continued…) In the HPLC Calibration – A complete guide article series, we have discussed about Monthly & Quarterly Calibration parameters, rest of the parameters are described below, in the end of the article all the relevant links has mentioned, in this article there are […]
HPLC Calibration- A complete Guide – Part 2 of 3
Continued from …. A Complete Guide on HPLC Calibration -Part 1 of 3 Part 2 – HPLC Calibration on different Parameter starts from Energy check and completed on wavelength accuracy of Detector In the previous article on HPLC Calibration we have covered following parameters. Pressure Test. Drift and Noise Column oven and sample cooler Pump […]
HPLC System Calibration- A Complete Guide Part 1
HPLC System Calibration is the most critical activity in the laboratory, HPLC System is the most sophisticated instrument in the Pharmaceutical Laboratory. Calibration of an instrument is the demonstration that the instrument or device produces results within specified limits by comparison with those produced by reference or traceable standard over an appropriate range of measurement. […]
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 […]
Product Recall Procedure and Format
The drug product recall is a process of removal or correction of marketed products for the reasons relating to deficiencies in quality, safety or efficacy, including labeling considered to be in violation of the laws. SOP for Product Recall 1.0 PURPOSE The purpose of this SOP is Effective and speedy withdrawal/ removal of […]
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 […]
Product Recall Procedure and Format
The drug product recall is a process of removal or correction of marketed products for the reasons relating to deficiencies in quality, safety or efficacy, including labeling considered to be in violation of the laws. SOP for Product Recall 1.0 PURPOSE The purpose of this SOP is Effective and speedy withdrawal/ removal of […]
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