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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: […]

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. […]

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 […]

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 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 […]

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 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 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, […]

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 […]

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 […]

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 […]

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 […]