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Use of latest FFS Technology
Strong Quality Assurance & Quality Adherence..
Strong Quality Control System.
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Committed & Veteran Staff at all level.
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Plant is maintaining all the documents by electronically and manually as per requirements of Quality Management System as a means of ensuring that products manufactured conforms to specified requirements.
Major Documents includes Site Master File, Validation Master Plan, Quality Manual, Training Manual, Master Formula of Products, Standard Operating Procedure and supporting records.
Product Information, Packing Information, Composition, Processing, Manufacturing, Inprocess checks and other instructions, testing etc. are mentioned in all Master Formulas for individual Products. These Master Formula’s are Approved by Head-QA. The same contains specimen of Packing Material etc.
Standard Operating Procedure (SOP) on Preparation, Review, Approval, Authorization & Control of SOP is available. Separate SOP on Documentation & Data Control is also available which describes the entire documentation system.
Standard Operating Procedure consists of documented procedures which define in detail the activities and responsibilities of all the personnel involved in administration and operation of the Quality System. All Standard Operating Procedure (SOPs) are prepared by respective department representatives, checked by Head of the Department, Approved by Head-QA and Authorized by Plant Head.
However, if any change is required due to any reason, the revision is done after getting permission from Head-QA. Distribution and recall of all the SOP’s are Authorized by Plant Head. Review of SOP’s is done in every two years.
All details regarding Site is available in this particular document as per cGMP. It includes Company Profile, Employees, Key Personnel and Job Responsibilities, Training, Premises, Manufacturing Operations, Equipments and Machineries, QA/QC Activities, Floor Plans & Process Flow Charts, Annexure etc. The SMF is Prepared by QA Department which is Approved by Head-QA and Authorized by Plant Head.
Revision of Site Master File is done in every one year or whenever required.