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STABILITY STUDY PROTOCOL TEMPLATE – Pharmaceutical Industry

STABILITY STUDY PROTOCOL TEMPLATE (FOR ASPIRIN TABLETS 75mg) Prepared By Checked By Approved By         Designation: Designation: Designation: Date: Date: Date: Sr. No. Content Page No. 1 Objective of study   2 Responsibilities   3 Product details   4 Packaging and batch details   5 Test parameters and specification   6 Testing schedule   7 Storage condition and stability duration   8 Sample quantity   9 Significant change criteria   10 Test procedure and criteria   11 Report generation   ...

Validation Master Plan for Pharmaceutical Industry

Author of the document Prepared by         Designation: Signature Date: Reviewer of the document for correctness Reviewed by:         Designation: Signature: Date: Approver of the document for use Approved by: Designation: Signature: Date:         Table of contents: 1. Validation policy 2. Scope 3. Responsibility 3.1 Production department 3.2 Quality control department 3.3 Engineering department 3.4 Quality assurance department 4. Site...

SOP for Microbiological Analysis of Compressed Air and Nitrogen

1. Objective: To lay down a procedure for microbiological analysis of compressed air and Nitrogen. 2. Scope: This procedure is applicable for microbiological analysis of compressed air and Nitrogen used at factory for manufacturing and testing. 3. Responsibility: Quality...

SOP for Microbiological Analysis of Compressed Air & Nitrogen

1. Objective To lay down a procedure for microbiological analysis of compressed air and Nitrogen. 2. Scope This procedure is applicable for microbiological analysis of compressed air and Nitrogen used at factory for manufacturing and testing. 3. Responsibility: Quality...

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 SOP is applicable for presently installed / available / planned...

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 water plant. Responsibility: Engineering, Purchase, Warehouse and QC department. ...

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 product quality, efficacy and patient safety. Responsibility: All concerned Department,...

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 procedure is applicable for following documents: - Quality Manual/Policy -  Site...

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