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
preparations contain other...
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...
To lay down a procedure for cleaning and sterilization of bulk storage tank during batch to batch and product to product cleaning.
This procedure is applicable for cleaning and sterilization of bulk...
Author of the document
Reviewer of the document for correctness
Approver of the document for use
Table of contents:
1. Validation policy
3.1 Production department
3.2 Quality control department
3.3 Engineering department
3.4 Quality assurance department
To lay down a procedure for failure investigation.
This procedure is applicable for investigation of process or system failure having impact on product quality, efficacy and patient safety.
All concerned Department,...
To lay down a procedure for origination and review of the Site Master File, Quality Manual, Quality Policy, SOPs, forms and logs.
This procedure is applicable for following documents:
- Quality Manual/Policy
To lay down a procedure for validation/qualification policy for equipment, system and instruments.
This procedure is applicable for production/engineering equipment, utilities and laboratory instruments.
Production, Quality Control, Engineering, other concerned department, Quality assurance
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...