This category includes Validation and Qualification related sops of pharmaceutical plant

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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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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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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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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Analyst Qualification of Quality Control Personnel

Standard Operation Procedure (SOP) of providing training and qualification of analyst for all new appointed personnel, and existing employees who are responsible for sampling & testing of incoming materials, in process samples and finished products. Analyst Qualification Procedure 1.0   Objective : To lay down a procedure of providing training and qualification of analyst for all new appointed personnel, and existing…

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Working Standard Qualification Procedure

Guideline for Laboratory Standard Management (Preparation, Qualification and Handling of Analytical standards/Working Standard/Primary Standard etc.) Working Standard Management 1.0   Objective : To lay down a procedure for the Preparation, Qualification and Handling of Analytical standards (Working Standard, Reference Standard & Primary Standards). 2.0   Scope : This SOP is applicable in Quality Control for the Preparation, Qualification and Handling of Analytical…

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Preservative Efficacy Test – The Complete Procedure

Standard Operating Procedure (SOP) and Guideline for Preservative Efficacy Test in Microbiology Laboratory for checking of effectiveness of preservatives added in the drug formulations. Procedure for Preservative Efficacy Test 1.0   Objective : To lay down a procedure for preservative efficacy test. 2.0   Scope : This guideline is applicable  in Microbiology Laboratory for checking of effectiveness of preservatives added in the…

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New Product Introduction Procedure and QRM

Standard Operating Procedure and Guideline for New Product Introduction in existing set of product list and equipment trail and Quality Risk Management at Pharmaceuticals Drug Manufacturing Plant. Guideline for  Introduction of Product 1.0   Objective : To lay down the procedure for introduction of new product at the manufacturing location. 2.0   Scope : This guideline is applicable for Introduction of new…

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Technology Transfer Procedure of Drug Product

Guideline for Technology Transfer. Tech Transfer is a systematic procedure that contains the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites to produce similar quality products. It is a systematic procedure that is followed in order to pass the documented knowledge and experience gained during development and or commercialization…

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Quality Risk Management (QRM) – ICH Q9

Standard Operating Procedure (SOP) & Guideline for Quality Risk Management (QRM) i.e. risk identification, analysis, evaluation, reduction/ mitigation, communication and conclusion of risk in order to ensure the quality, safety, integrity and purity (SISPQ) of the drug product. Quality Risk Management (QRM) 1.0   Objective : To lay down the procedure for risk identification, analysis, evaluation, reduction/ mitigation, communication and conclusion…

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Cleaning Validation (CV) Procedure and Protocol

Standard Operating Procedure (SOP) and Guideline for performing Cleaning Validation (CV) of drug product manufacturing equipments. Cleaning Validation (CV) 1.0   Objective : To lay down the procedure for Cleaning Validation (CV) of manufacturing equipments. This Guideline describes the validation of cleaning procedures (CV) for the removal of contaminants associated with the previous products, residues of cleaning agents as well as…

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Change Control Process and Management in Pharma

Standard Operating Procedure (SOP) for Procedure, Process and Management of Change Control (temporary change or permanent change control) in the pharmaceutical drug manufacturing plant. Change Control Management 1.0   Objective: To lay down the procedure to identify, initiate, evaluate, review, approve, implement, and regularize the change through a change control system. 2.0   Scope - SOP for Change Control: This procedure covers…

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Stability Study of Drug Product as per ICH Q1A(R2)

Standard Operating Procedure (SOP) for Stability Study of Drug Product as per ICH Q1A(R2). The term (Stability Study) with respect to a drug dosage form refers to the chemical & physical integrity of the dosage unit & when appropriate, the ability of the dosage unit to maintain protection against microbial contamination. Stability Study Guideline 1.0   Objective: To lay down a…

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Self Inspection & Internal Audit Procedure in Pharma

Standard Operating Procedure (SOP) for Self Inspection (Internal Audit) of various departments/sections and functions of the pharmaceutical drug manufacturing plant. Self Inspection (Internal Audit) Procedure 1.0   Objective : To lay down the procedure for conducting the self-inspection (Internal Audit) in order to implementation of  Quality Management System and compliance with GMP practice principles, Data integrity, and to propose necessary corrective…

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Self Inspection Checklist & Internal Audit Formats

Self Inspection (Internal Audit) Checklist for various departments/systems and functions of the pharmaceutical manufacturing plant. These checklists are applicable for inspection of the Company’s operations directly or indirectly connected with Manufacturing, Stores, Dispensing, Sampling, Packaging, Quality Control, Microbiology, Engineering,  IT, personnel, safety, Documentation, etc. Self Inspection Checklists List of Self Inspection (Internal Audit) Checklists - Stores & Ware House Self…

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