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…
Category: SOPs
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:…
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…
SOP for Incident Handling in Pharmaceutical Industry: PharmaState
1. Objective: To lay down a procedure for handling of incidents. Scope: This procedure is applicable for accidental and untoward events occurring in factory premises. Incidents…
SOP on Calibration Management in Pharmaceutical Industry
Objective: To lay down a procedure for management of calibration procedure. Scope: This procedure is applicable for QC instruments, production equipment, utility service and all other…
SOP on Vendor Qualification/Approval in Pharmaceutical Industry
1. Objective: To lay down a procedure for vendor approval. Scope: This procedure is applicable for vendors supplying raw materials and packaging materials. Responsibility: Quality…
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