CALGS has developed manuals for use by pharmaceutical and medical device industry. The objective, of developing these manuals, is to help the industry understand the subject and use them in their day to day operations. The content and its sequencing in the manual are such that after going through the material, an individual becomes plausibly aware of the requirements and its interpretations.
     
GMP MANUAL    
     
CALGS has compiled an extensive GMP manual. It contains description of how to implement GMP, provides examples & templates and includes numerous checklists, documents and cross-references. Language of the manual is user friendly. This 565 page document consists of 13 chapters and 4 annexure. The contents of the manual are:
 
     

CHAPTERS:

     
  • General
  • Quality Philosophy
  • Building & Premises
  • Documentation
  • Personnel
  • Material Management
  • Packaging
  • Preliminary Statistics
  • Packaging & Labeling
  • Hygience & Sanitation
  • Water System
  • Validation
  • Factory Inspection

GMP Manual Contents
     

QA MANUAL

     
    Quality Assurance is a wide ranging concept that covers all matters that individually or collectively influence the quality of a product. Therefore QA is not the duty of a single unit in the company alone, but a responsibility of all staff members who in a way can influence product quality. Most of the LSI & MSI do have QA departments, and for SSI QA is a term introduced recently and hence they are still in the process of understanding the term and its functions.

    CALGS has compiled an extensive QA manual. This document consists of 13 chapters and 4 annexure. The contents of the manual are:
     
     
    CHAPTERS:
     
    • General
    • Quality Philosophy
    • Regulatory Affairs
    • Good Manufacturing Practices
    • Training imparted by QA
    • Documentation
    • Standard Operating Procedures
    • Specifications & Quality Plans
    • Calibration
    • Validation & Qualification
    • Handling External Audit & Compliance Reporting
    • Complaint Handling & Recall

    QA Manual Contents
         
    The CALGS Training Manuals are valuable source of training material for quality assurance, quality control, production, stores, purchase personnel. Hence, companies as well as individuals can purchase this manual.
     
       

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