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SOP – Good Documentation Practices in Pharma Industry

1.Objective : To lay down a procedure for good documentation practices. 2. Scope: This procedure is applicable to all cGxP documents (electronic & manually generated) used in the manufacturing, packaging, labeling, testing, storage and distribution of Drug...

SOP of Signature Log | Pharmaceutical Industry

1. Purpose :  To lay down the procedure for signature log. 2.Scope :  This procedure is applicable to all employees working in a company...

SOP ON SOP (HOW TO PREPARE SOP) – PHARMACEUTICAL INDUSTRY

1.Objective To lay down procedure for preparation, review, approval, issuance & retrieval of Standard Operating Procedure. (SOP) 2.Scope This procedure is applicable to preparation of SOP for all the cGMP activities. 3.Responsibilities User Dept. QA Dept. 4.Procedure: The procedure is described further into sub parts. i.e....

SOP for User Requirement Specification in Pharmaceutical Industry

Objective To lay down a procedure for User requirement specification (URS).ScopeThis is applicable mainly to production equipment and utility systems. It shall also be applicable to analytical instruments and building facility with appropriate change...

SOP for Document Numbering System

1. Objective To lay down a procedure for preparation of policy documents and numbering of qualification and validation documents. 2. Scope The SOP is applicable for policy documents related to quality Management systems and also provides guideline...

SOP for Product Recall in Pharmaceutical Industry

1. Objective To lay down a procedure for product recall. 2. Scope This procedure applies to the recall of a batch or batches of any product for which the company is licenced holder, authorised distributor or importer 3....

SOP for Performance Qualification of LAF, RLAF and Dynamic Pass Box

    1. Objective: To lay down a procedure for performance qualification of LAF, RLAF and dynamic pass box. Scope: This procedure is applicable for performance qualification of LAF, RLAF and dynamic pass box Installed...

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   ...

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