SOP for Computer System Validation in Pharmaceutical Industry
Objective: To lay down a procedure for computer system validation. Scope: This procedure is applicable for all computerized system used in GxP regulated activities. This…
Category: Pharma Industry Guidelines
SOP for Management of Chemicals used in Purified Water Plant in Pharmaceutical Industry
Objective: To lay down a procedure for management of chemicals used in purified water plant. Scope: This procedure is applicable for chemicals used in purified…
SOP for Failure Investigation in Pharmaceutical Industry
Objective: To lay down a procedure for failure investigation. Scope: This procedure is applicable for investigation of process or system failure having impact on…
Important SOPs for Microbiology Department in Pharmaceutical Industry
SOP for aerobic microbial count SOP for operation and maintenance of microscope SOP for operation and maintenance of BOD incubator SOP for sterility testing…
SOP for Management of External Calibration/Validation Agency in Pharmaceutical Industry
Objective: To lay down a procedure for evaluation and approval of external calibration/validation agency. Scope: This SOP is applicable for all external service providers for calibration/validation …
SOP for Quality Management System (Documentation) in Pharmaceutical Industry
Objective: To lay down a procedure for origination and review of the Site Master File, Quality Manual, Quality Policy, SOPs, forms and logs. Scope: This…
SOP for Validation/Qualification Policy in Pharmaceutical Industry
Objective: To lay down a procedure for validation/qualification policy for equipment, system and instruments. Scope: This procedure is applicable for production/engineering equipment, utilities and laboratory instruments. Responsibility:…
Quiz on Sterilization of Pharmaceutical Product – 103
[wp_quiz id=”3498″] Disclaimer: The information in this Quiz was compiled from sources believed to be reliable for informational purposes only. We do not guarantee the…
EudraLex Volume 4 – Good manufacturing Practice (GMP) guidelines
Summary of contents Part I- Basic Requirement for medicinal products Part I has following 9 chapters: Chapter 1: Pharmaceutical quality system Chapter 2: Personnel Chapter…
SOP for Repacking of Products in Pharmaceutical Industry
1. Objective: To lay down a procedure for repacking of finished products. Scope: This procedure is applicable for repacking activities of finished products to be…
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