Standard Operating Procedure (SOP) to define the procedure for operation and regeneration of the Purified Water Plant (Mixed bed unit). SOP for Purified Water Plant 1.0   PURPOSE: To define the procedure for operation and regeneration of Purified Water Plant (Mixed bed unit). 2.0   SCOPE: This procedure is applicable to the operation and regeneration of the […]

Standard Operating Procedure (SO) for Operation and Calibration of Auto Titrator (Potentiometer) for its utility in carrying out different types of Titration SOP for Auto Titrator (Potentiometer) 1.0   PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for the Operation and Calibration of the Auto Titrator for its utility in […]

Residual solvent in pharmaceuticals is defined here as organic volatile chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug products. LIMIT OF RESIDUAL SOLVENTS IN DRUG PRODUCT 1.0   Purpose: The purpose of this Standard Operating Procedure (SOP) is to describe the limit of residual […]

Standard Operating System (SOP) issuance, controlling, and management of different Protocols and its numbering System in pharmaceuticals for different activities. A protocol is a written statement to conduct the validation process along with the procedure, test method, equipment handling, specifications, acceptance criteria, report, and approval. Protocol Numbering System 1.0   PURPOSE: The purpose of this SOP […]

Standard Operating Procedure (SOP) for the recording of Specimen Signatures of Employees and contract personnel. Specimen Signature is a copy of your name written by yourself that an organization keeps so that they can be sure that your name on a document was also written by you. SOP for Recording of Specimen Signature 1.0   PURPOSE: […]

Standard Operating Procedure (SOP) for Operation, Cleaning, and Performance Check for Refrigerator used to store the  Microbiology Culture, Spores, Media, etc in the Microbiology Lab. Refrigerator Used in Microbiology Lab 1.0   Purpose: The purpose of this SOP is to describe the Operation, Cleaning, and Performance check procedure of Refrigerator used for the storage of microbiology […]

This SOP provides guidance to evaluate the potential of the proposed new product for cross-contamination and assessment of the containment approach required to manufacture the new product at Manufacturing and Packaging Facilities. For existing products, Quality Risk Management for Cross-contamination shall be performed as per SOP “Prevention of cross-contamination, Mix up and Microbial Contamination” for […]

Calibration Procedure / SOP for Ultra Performance Liquid Chromatography (UPLC) System. UPLC can be regarded as a new direction for liquid chromatography. UPLC refers to ultra-performance liquid chromatography, which improves in three areas: “speed, resolution, and sensitivity”. This Procedure is applicable for Waters Make UPLC – Aquity, UPLC – H Class, Thermo Make U-HPLC Systems, […]

Standard Operating Procedure (SOP) for operation and maintenance of the Oven used to determine the Loss on Drying (LOD) in the Quality Control Department. Loss on drying (LOD) is the loss of weight expressed as percentage w/w resulting from water and volatile matter of any kind that can be driven off under specified condition. SOP […]

Standard Operating Procedure (SOP) for Operation, Cleaning, and Calibration of Flame Photometer used in inorganic chemical analysis to determine the concentration of certain metal ions, among them sodium, potassium, lithium, and calcium. SOP for Flame Photometer 1.0   PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the operation and calibration of the […]

Standard Operating Procedure (SOP) and Detailed Risk Assessment approach for Prevention of Cross Contamination, Mix-ups, and Microbial Contamination. Prevention of Cross Contamination, Mix-Ups & Microbial Contamination 1.0   PURPOSE: The purpose of this procedure is to ensure that the manufacture of all finished drug products and Active Pharmaceutical Ingredients is accompanied by risk-based approaches and controls […]

Standard Operating Procedure (SOP) for Operation and Cleaning of Electromagnetic Sieve Shaker which is used to determine the particle size of pharmaceutical starting material (API and Excipients). SOP for Electromagnetic Sieve Shaker 1.0   Purpose: The purpose of this SOP ( Standard Operating Procedure) is to describe the operation of Electromagnetic sieve shaker. 2.0   Scope: This […]

Standard Operating Procedure (SOP) cum Guideline for Good Documentation Practices for cGxP documents (Electronic and Handwritten) Pharmaceutical Drug Manufacturing Plants. Guideline for Good Documentation Practices 1.0   PURPOSE: This Standard Operating Procedure (SOP) defines the requirements for the compliant, consistent, and accurate completion of Good Documentation Practices. 2.0   SCOPE: This standard applies to cGxP documents (electronic […]

Standard Operating Procedure (SOP) for Operation and Cleaning of COBB TESTER used for the analysis of packing/packaging material in the Quality Control Laboratory. SOP for Cobb Tester 1.0   Purpose : The purpose of this SOP is to describe the procedure for the operation and cleaning of Cobb tester. 2.0   Scope : This SOP is applicable […]

Standard Operating Procedure (SOP) and Format/Protocol for Calibration of HPLC system (Parameters are Pressure test, Drift and Noise, Flow Rate Accuracy, Autosampler by carryover check,  detector by linearity measurement, etc.) Calibration of HPLC System 1.0   PURPOSE: The purpose of this SOP is to describe the Procedure for Calibration of high-performance liquid Chromatography in Quality Control. […]