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Corporate Quality Manual

INTRODUCTION TO THE - CORPORATE QUALITY MANUAL - ....................CLICK HERE FOR OUR MESSAGE BOARD....................CLICK HERE FOR FDA COMPLIANT SITUATIONS VACANT....................CLICK HERE FOR THE LATEST ON TEMPERATURE MAPPING & LOGGING....................CLICK HERE TO GO TO THE DOCUMENT STORE
Our Corporate Quality Manual documents the policies, procedures, responsibilities, and documentation, that must be in place for the company to comply with their regulatory responsibilities.
Well designed and interactive templates are included in the manual contents. Important and mandatory GMP and FDA compliant documentation, including, VMP, VP, URS, OQ, IQ, PQ, DQ, are there ready for use.
This CQM contains procedures and policies that enforce cGMP and ensure FDA Compliant procedures that provides information and compliance visibility throughout the organization in real-time, and are applied throughout the company and not just to the quality assurance department. A closed loop CAPA system that is capable of minimizing the possibility of receiving CAPA - 483, related warning letters. The system is capable of identifying problems and highlighting them for correction, prior to any becoming potential liability issues.
Authoring and publishing a CQM is a long drawn out and expensive process. A single author will usually take six to nine months to produce one. A similar amount of time is required from peers, in reviewing and editing. This must be taken into consideration when deciding whether to purchase a generic manual or to self author from scratch.
Our manual preface is constructed as an SOP. This SOP takes you through the simple stage of populating the CQM. This simple process populates your company details throughout the manual, turning this standard manual into your new company bespoke manual.

The cost of producing a CVM can be estimated, just by considering the man-hours involved.

Click here and go to the document store to purchase now.

CORPORATE QUALITY MANUAL

Corporate Quality Manual

The Under listed is a list of the chapter and sub-chapter headings from our VMP. The document is made as an interactive template.
  • CVM Information.
  • Introduction.
  • Glossary.
  • General Principles of Company Validation.
  • Material Qualification.
  • Process Validation(PQ).
  • Sterile Formulations.
  • Solid Oral Dosage Formulations.
  • Fluid and Semi-solid non-sterile Formulations.
  • Devices.
  • Biological Products.
  • Active Pharmaceutical Ingredients.
  • Facilities and Utilities Validation.
  • Test Method Validation.
  • Cleaning Validation.
  • Equipment Qualification.
  • Sterilization Validation.
  • Validation of Steam sterilizer Cycles.
  • Computer Validation. (CSV)
  • Aseptic Process Validation.
  • Sanitization Validation.
  • Microbiological Validation of Clean Rooms.
  • Performance qualification includes but is not limited these alone:
  • Verification of performance criteria and test procedures.
  • Verification of critical parameters, attainment, control and monitoring.
  • Determination of the test intervals.

Corporate Quality Manual


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