QUALITY ASSURANCE SYSTEM

It is the sum total of the organized arrangements made with an object to ensure that the products will be of quality required for their intended use. It is Good Manufacturing Practice plus factors such as original product design, assessment of authorized development work and review of any abnormal factors identified during and after manufacture.

QUALITY POLICY

Mission’s Quality Policy has a broad base, with stringent specifications to ensure all Quality parameters. Our strong belief in quality is not only restricted to conformance of written specifications but also to build all employees into a team that believes in quality in the product at every stage of manufacture. The system is designed in such a way that all aspects of G.M.P. and G.L.P. are followed by means of using :

  • Best available resources
  • Vendor Rating and Approval
  • Good Product Design
  • Validated Processes
  • Well Trained Personnel
  • Stringent Quality Control
  • Effective Quality Assurance

IMPLEMENTATION OF QUALITY POLICY

To achieve quality objective a strong Quality Assurance System has been formulated incorporating Good Manufacturing Practices and Good Laboratory Practices.

The main and broad functions are :

  • Perform Vendor Evaluation
  • Oversee all Quality Control Norms
  • Perform Process Evaluation
  • Examine current methods of analysis to confirm suitability
  • Interact with R&D to evaluate suitable specifications for Raw Materials, Packing Materials and Finished Products.
  • Monitor on going Stability Studies
  • Review MFR Periodically
  • Ensure GMP and GLP at all stages
  • Investigates market complaints and product recalls
  • Preserve control samples, working standards etc.
  • Assist in self-quality Audit
  • Periodically conduct Self-Inspection and Audit
  • Co-ordinate and provide appropriate training to all Personnel
  • Review all Statutory compliances

Quality Assurance Department approves the following documents generated by Production Sections.

  • Master Formula Record of each Product
  • Batch Manufacturing Record
  • Batch Packing Record
  • Batch Dockets
  • I.P.Q.C. / Process Control Records
  • Standard Operating Procedures
  • Standard Cleaning Procedures
  • Periodical review of all the above documents
  • Updating as per the Standard Norms

QUALITY CONTROL

Quality Control is that part of Quality Assurance System which is concerned with sampling, specifications and testing within the organization, documentation and release procedures which ensure that necessary and relevant tests are actually carried out and that materials are not released for use nor products released for sale and supply until their quality has been confirmed to satisfactory. Quality Control Personnel perform the following functions :

  • Inspect the consignment, perform sampling and analysis at various stages of manufacturing operations.
  • Assign reference number for release of Raw materials, Packing materials and Finished products.
  • Assign reanalysis data etc. for various materials & advise store on their storage conditions.
  • Preserve control samples, working standards etc.
  • Monitor ongoing stability studies.
  • Verify dispensing of the Materials as per BMR in the dispensing area.
  • Review records, control samples and ensure disposal of old records, samples etc.
  • Preserve reports, records and documents.
  • Assist in calibration of in-process control instruments, laboratory instruments.
  • Validation of equipments, processors etc.
  • Ensure proper disposal of rejected material / products.
  • Monitor line clearance, in-process control review and approve BMRs.
  • Monitor line clearance, in-process control review and approve BMRs.
  • Release finished products for sale.

TESTING CARRIED OUT AT PUBLIC TESTING LABORATORY

While adequate facilities are provided in-house for all testing and evaluation, for some of the tests where it is not commercially viable as yet, outside assistance is obtained.

Public Laboratories are identified and chosen by a systematic evaluation and approval. Such contract Laboratories are periodically inspected based on the frequency and feasibility in a progressive manner. Increased Self-reliance will be achieved.

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