This category includes Quality Assurance SOP’s.

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…

2 Comments

Batch Manufacturing Record (BMR) Management

Standard Operating Procedure for Preparation, Checking, Approval, authorization & issuance of Master Formula Record, Batch Manufacturing Record (BMR) & Batch Packaging Record (BPR). Batch Manufacturing Record (BMR) & Batch Packaging Record (BPR)  Management 1.0   Objective : To lay down the procedure for Preparation, Checking, Approval, authorization & issuance of Master  Formula Record (MBR), Batch Manufacturing Record (BMR) & Batch Packaging…

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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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Process Validation (PV) & Verification of Drug Product

Standard Operating Procedure (SOP), Guideline and Protocol for Process Validation and Verification for Drug Product (Tablet, Capsule etc.) Process Validation (PV) Procedure 1.0   Objective : To lay down the procedure for Process Validation of pharmaceuticals products. Process validation provides documented evidence that a process is capable of reliably and repeatedly render a product of the required quality. 2.0   Scope :…

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Deviation (Planned and Un-planned) Control System

Standard Operating Procedure (SOP) for identification, Investigation, approval, and trending of Deviation (s) which may occur during manufacturing, packaging, or any other operation/activity. Deviation Control Management 1.0   Objective : To lay down a procedure for identification, Investigation, approval, and trending of Deviation (s) which may occur during manufacturing, packaging or any other operation / activity. This SOP defines key system…

6 Comments

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…

6 Comments

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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Line Clearance of Process during Drug Manufacturing

Standard Operating Procedure (SOP) for Line Clearance (LC) during the manufacturing process of pharmaceutical drug products. The term line clearance is used for the documented act of conducting any necessary removal of products and materials from a manufacturing/ packaging line to prepare the line for the next production. Line Clearance (LC) Procedure 1.0   Objective : To lay down the procedure…

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General Information – Pharmaceuticals Quality Control

Quality control is an essential operation of the pharmaceutical industry. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. In this article, Common words being described which are generally used in pharmaceutical Quality Control. Definition of Terms Used in Quality Control Laboratory 1.0   Description - Quality Control Tests: Statements given under this heading…

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