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:…
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…
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…
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…
1. Objective: To lay down a procedure for handling out of trend (OOT) results during laboratory analysis. Scope: This procedure is applicable for chemical, physico-chemical…
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…
Objective: To lay down a procedure for data integrity as part of quality management system. Scope: This procedure is applicable for all the data associated…
Preparation, review, approval and control of SOPs Training procedure Handling and control of documents Change control Handling of deviations SOP for line clearance Handling of…
Objective: To lay down a procedure for finished product inspection and release. Scope: This procedure is applicable for all type of finished pharmaceutical product. Responsibility:…
“It is documented evidence that an approved cleaning procedure will provide equipment which is suitable for processing or manufacturing of medicinal products” It is based…
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