This category includes Quality Assurance SOP’s.
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…
Standard Operating Procedure (SOP) & Guideline for Handling of Market Complaint of Drug Product. Any complaint, written or verbal, received directly from the customer, retailer, distributor, field staff or any Government Agencies regarding purity, labeling defects, shortages etc. such complaints shall be considered as a market complaint. Handling of Market Complaint 1.0 Objective : To lay down the procedure for…
Standard Operating Procedure (SOP) and Guideline for the classification of different types of Quality defects that may be encountered in Tablets/Capsules and the Acceptance Quality Limits (AQL) for the same. Acceptable Quality Limit (AQL) 1.0 Objective : To lay down a procedure for the classification of different types of Quality defects that may be encountered in Tablets/Capsules and the Acceptance…
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…
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…
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…
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…
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 :…
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…
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)…
Standard Operating Procedure for Mock Recall and Drug Product Recall, The drug product recall is a process of removal or correction of marketed products for the reasons relating to deficiencies in quality, safety, or efficacy, including labeling considered to be in violation of the laws. SOP for Mock Recall & Drug Product Recall 1.0 Objective : To lay down a…
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…
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…
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…
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…
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…
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…
