Standard Operating Procedure for Dispensing of Raw Material (API-Active Pharmaceutical Ingredient and Excipient) to the production department for the manufacturing of pharmaceutical drug products.  1.0        PURPOSE: The purpose of this SOP is to define the procedure for dispensing of Raw Materials. 2.0      SCOPE: This procedure is applicable for dispensing of […]

Standard Operating Procedure for Qualification, Handling and Usage Of Reference Standards, Calibration Standards, Impurity Standards, Working Standards, and Working Standard Solvents. SOP for Laboratory Standard Management 1.0      PURPOSE: The purpose of this SOP is to describe the procedure for qualification, handling, storage and usage of reference standards (RS), calibration standards, impurity standards (IMS), […]

Standard Operating Procedure (SOP) for Electronic data backup, restoration, archival, retrieval and scheduled verification of stored data of quality control laboratory. SOP for Electronic Data Management (Laboratory) PURPOSE The purpose of this Standard Operating Procedure (SOP) is; To provide the procedures for Backup, Restoration, Archival and Retrieval of electronic data generated by Stand Alone/Server based […]

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 […]

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, […]

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 […]

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 […]