Production

Know about:- Oral Liquid Formulations

The oral liquids are homogenous liquid preparations, which contain an emulsion, solution or suspension of one or more active ingredients that are suitable as liquid base. These preparations are administered either as is or after dilution. The preparations contain other...

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 Cleaning and Sterilization of Bulk Storage Tank

1. Objective: To lay down a procedure for cleaning and sterilization of bulk storage tank during batch to batch and product to product cleaning. Scope: This procedure is applicable for cleaning and sterilization of bulk storage tank...

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 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, Quality Assurance Procedure:...

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 Master File - ...

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 every new or existing...

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 3: Premise and Equipment Chapter 4: Documentation Chapter 5: Production Chapter 6: Quality control Chapter 7: Outsourced...

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