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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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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GC Columns (Gas Chromatography) Management

Standard Operating Procedure for Receipt, Issuance, Performance, Regeneration, Use, Cleaning, Storage and Rejection of GC Columns. GC Column Management 1.0   Objective To lay down the procedure for Receipt, Issuance, Performance, Regeneration, Use, Cleaning, Storage and Rejection of GC Columns. 2.0   Scope This SOP is applicable for all the GC columns used in Quality Control Laboratory 3.0   Procedure for GC Columns…

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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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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 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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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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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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Raw Material Sampling Procedure-API & Excipient

Standard Operating Procedure (SOP) and Guideline for sampling of raw material (API and Excipient) / Starting material for analysis. Raw Material Sampling Procedure 1.0   Objective : To lay down a procedure for sampling of raw materials.  2.0   Scope : This SOP is applicable for sampling of raw materials at pharmaceutical drug manufacturing plant.           3.0   Procedure :…

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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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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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Corrective and Preventive Action (CAPA)

Standard Operating Procedure (SOP) for various investigation tools for finding the root causes that enables determination of corrective and preventive action (CAPA). Handling of Corrective and Preventive Action (CAPA) 1.0   Objective : To describe the procedure describing various investigation tools for finding the root causes that enables determination of corrective and preventive actions. To identify quality issues and GMP issues…

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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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APQR – Annual Product Quality Review in Pharma

Standard Operating Procedure for Annual Product Quality Review (APQR), also known as Product Quality Review (PQR) and Annual Product Review (APR) preparation. Procedure for Annual Product Quality Review (APQR) 1.0   Objective: To lay down the procedure for carrying out the Annual Product Quality Review (APQR). The purpose of this SOP is to describe the procedure for Product Quality Review (APQR)…

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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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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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