This category includes Quality Assurance SOP’s.

Top Loading Balance – Operation and Calibration SOP

Standard Operating Procedure for Operation and Calibration of Top Loading Balance used in the pharmaceutical industry, guideline, and formats of uses and calibration/qualification. Operation & Calibration Procedure for Top Loading Balance 1.0   Purpose : To lay down a procedure for Operation and Calibration of Top Loading Balance. 2.0   Scope :  This SOP is applicable for Top Loading Balance used in…

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Data Integrity Incident Handling Procedure

Standard Operating Procedure (SOP) for Handling of Data Integrity Incident Investigation and compliance in Pharmaceutical Drug Manufacturing Plant. Handling of Data Integrity Incident 1.0   PURPOSE: To provide a procedure to investigate and handle data integrity incidences related to GXP data, identified during internal audit or during review of data. 2.0   SCOPE: Applicable to all GxP data generated by electronic and…

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Transport Validation – Guideline & Protocol

Standard Operating Procedure (SOP) and Protocol for Transport Validation through temperature mapping during transit of drug products. Transport Validation Procedure 1.0   Objective To lay down the procedure for conducting transport validation and to describe acceptance criteria for the study. The purpose of this SOP is to provide detailed steps to conduct transport validation and to evaluate the product integrity and…

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Documents and Data Control in Pharmaceuticals

Documents and Data Control is a function or department which keeps track of all documentation, specifications, and processes. The purpose is to ensure that everyone uses the correct and current document processes and specifications. Documents and Data Control 1.0   Objective To lay down a procedure for control of documents and documented data. 2.0   Scope This SOP is applicable for the…

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Reprocessing Reworking & Redressing of Product

Reprocessing and reworking are considered non-routine events. Reprocessing: reprocessing is the introduction of an in-process material or drug product including one that does not conform to a standard or specification back into the process and repeating steps that are part of the approved manufacturing process / Primary packaging process. Continuation of a process step after a process test has shown…

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Tech Transfer Documents Handling Procedure

Standard Operating Procedure for the handling of Tech Transfer documents received from transferring unit (TU)/ generated at receiving unit (RU) during tech transfer activity. Tech Transfer Documents 1.0   Objective To lay down the procedure for Handling Tech transfer documents for the products to be introduced/transferred at the site. 2.0   Scope This SOP is applicable to all Technology transfer (Tech Transfer)…

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Reduce Testing Procedure for Raw Material (API)

Standard Operating Procedure (SOP) for Reduce Testing in pharmaceutical starting materials (Raw Material) procured from approved vender. Reduce Testing Procedure 1.0   Objective To lay down a procedure for reduce the testing of raw materials. 2.0   Scope This SOP is applicable for Reduce Testing of raw materials procured from approved vender. 3.0   Procedure for Reduce Testing: Reduced Testing shall be done…

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Equipment Qualification Procedure and Protocol

Equipment Qualification is the final series of inspections and tests to ensure that critical requirements necessary for related product quality are satisfied and that documents and procedures necessary to properly operate and maintain the system are in place. Equipment Qualification Procedure 1.0   Objective : To lay down the procedure for preparation of Qualification documents, execution of Qualification activities, Review and…

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Finished Product Release Procedure (SOP)

Standard Operating Procedure (SOP) for Finished Drug Product (Finished Goods) Release for Sale and Distribution including the review of batch documents and checkpoints. Finished Drug Product (Finished Goods) Release 1.0   Objective :  To lay down the Procedure for release of Finished Products for sale & distribution. 2.0   Scope : This procedure is applicable to all products manufactured at pharmaceutical drug…

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In Process Quality Assurance (IPQA) Check Points

Standard Operating Procedure (SOP) for In - Process Quality Assurance (IPQA) check points and procedure during manufacturing of drug product in pharmaceuticals. In process Quality Assurance (IPQA) Checks 1.0   Objective : To lay down procedure for monitoring the In - Process Quality Assurance (IPQA) activities in stores and Production. 2.0   Scope : The SOP is applicable in stores and production…

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Out of Specification (OOS) Handling Procedure

Guideline for Handling of Out of Specification (OOS) results occurs during analysis of Raw Material and Pharmaceutical Drug Products (Different stages like - In-process, Bulk, Intermediate, Finished Product & Stability Study Samples) Handling Out of Specification (OOS) Results 1.0   Objective : To lay down the procedure for investigation of Out of Specification (OOS) result(s) that occurs during sample testing in…

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Vendor Assessment / Evaluation Checklist

Checklist for Assessment or Evaluation of Raw material vendor (manufacturer of supplier). The Successful evaluation of Vendor’s ability and capability in meeting the company’s quality system requirements in relation to the criteria established for the material being sourced. Checklist for Assessment or Evaluation of Vendor Vendor Assessment / Evaluation Questionnaire ( Manufacturer ) Name of the Material   Questionnaire to…

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Vendor Audit & Qualification Management Procedure

Vendor Audit is an evaluation of vendor's manufacturing site, for product of interest(s), for the understanding and application of the cGMP. Successful evaluation of Vendor’s ability and capability in meeting the company’s quality system requirements in relation to the criteria established for the material being sourced. Vendor Audit and Qualification Guideline 1.0   Objective : To lay down a procedure for…

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Stability Chamber / Incubator Management Procedure

Standard Operating Procedure (SOP) for Management of Walk in and stand-alone Stability Chamber used for Stability Study and also to determine the self life of the drug product. Stability Chamber / Incubators Management 1.0   Objective : To lay down a procedure for Management of Walk in and stand-alone Stability Chamber. 2.0   Scope : This SOP is applicable for Management of…

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Cleaning Validation : Procedure & Protocol

Standard operating Procedure & Protocol for Cleaning Validation to prove that the equipment cleaning procedure can repeatedly and reproducibly remove residue of the previous product below established acceptance limit. The acceptance limit is maximum allowable quantity of product residue, which does not affect quality and safety of the subsequent product to be manufactured, by using same equipment and facility. Cleaning…

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Method Verification (Analytical) Procedure (USP1226)

Standard Operating Procedure for performing analytical method verification of compendial procedure/ validated analytical methods in quality control department. Describes characteristics for analytical method verification to be carried out for drug substances and drug products. Analytical Method Verification 1.0   Objective : To lay down the procedure for performance of analytical method verification of compendial procedure/validated analytical methods in quality control department.…

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Microbial Cultures – Isolation and Identification Guide

Procedure for Isolation and Identification of Microbial Cultures & Microbial Isolates using different Analytical Methods from the manufacturing environment of OSD, oral liquid, sampling & Dispensing area, Microbiology section and water isolates from water system, colony isolated from MLT positive results and Standard Microbial cultures. Isolation and Identification of Microbial Cultures & Microbial Isolates 1.0   Objective : To lay down…

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Failure Investigation Procedure and Tools

Standard Operating Procedure (SOP) for Failure Investigation (process failure as well as non-process failure) occurs during manufacturing or processing of drug products. Failure Investigation 1.0   Objective : To lay down the procedure for failure investigation of any activity to meet its predetermined specification, limits or acceptance criteria. 2.0   Scope : This SOP is applicable to process failure as well as…

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Analytical Method Transfer – Acceptance Criteria

This SOP describes the process and requirements for the transfer of analytical test method from an originating laboratory (Transferring Unit) to a receiving laboratory (Receiving Unit). This SOP provides the requirements for the transfer of validated analytical methods. It defines a process for preparing for transfer, executing transfer testing and preparing final reports. Analytical Method Transfer 1.0   PURPOSE: This SOP…

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