This category includes Validation and Qualification related sops of pharmaceutical plant
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…
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…
