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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: Production, Quality Control, Engineering, other concerned department, Quality assurance Procedure: 4.1 For...

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 carried   out at factory premises. Responsibility: Production, warehouse, quality...

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 may occur even though standard procedures are not violated. ...

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 equipment used for measurement. Responsibility: Quality control, Production, Warehouse,...

SOP on Handling Out Of Trend (OOT) Results

  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 and microbiological       results generated during laboratory analysis. Responsibility: Quality...

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 assurance, Purchase, Quality Control and Warehouse Procedure: 4.1 Procedure...

Important SOPs for Quality Control Department (Chemical section) in Pharmaceutical Industry

Sampling of raw material, packaging material, bulk, intermediate and finished product Raw material, packaging material, bulk, intermediate and finished product analysis Cleaning and storage of sampling equipment Preparation of specifications Procurement of laboratory...

SOP on Data Integrity in Pharmaceutical Industry

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 with GxP and quality management system. Responsibility: All department...

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