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Quality Control in Pharmaceutical Industry

Quality control in pharmaceutical Industry

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Quality Control in Pharmaceutical Industry

  1. 1. Qc is the part of GMP concerned with sampling, specifications and testing and with the organization, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and the materials are neither released for use, nor products are used for sale & supply until their quality has been satisfactory.
  2. 2.  Independence of QC from production is considered fundamental.  QC head should have appropriate qualification and experience, which has control over one or several labs.  Adequate resources must be available to ensure all quality control arrangements are effectively and reliably carried out.
  3. 3. Adequate facilities, trained personnel and approved procedures must be available for sampling, inspecting and testing of starting materials, packaging materials and intermediate bulk and finished products and where appropriate of monitoring environmental conditions for GMP purpose.
  4. 4. Quality Control QC labs Sampling Validation Records Analysis of Finished Product Retained Samples Batch Inspection and Sampling
  5. 5. QC LABS QC Labs 3.Microbioloy and Toxicology lab 6. Relevant Books 8. Trained Personnel 1. Chemical Testing Lab 5. Documentation Room 4. Provision for retained samples and stability samples 2. Instrumental Analysis Lab 7. SOPs
  6. 6. SAMPLING Sampling Sops for RM/FM/IM Approved method for sampling Well trained personnel and sampling tools Records maintenance of all sampling Checklist for every stage Sops divided into – before, during and after
  7. 7.  All the methods used by QC, say for sampling, testing and other activities must be validated.  Validation of testing method is particularly very important. VALIDATION
  8. 8.  Records must be made (manually and/or by recording instrument) demonstrating that all the required sampling, inspecting, testing procedures have been actually carried out and that any deviation have been recorded and investigated.  Recording is the primary basis of any pharmaceutical activity and hence all regulations insist on recording of each and every activity carried out. This helps in tracing the history of a batch produced; this may be required in future if any investigation is to be made.  The basic concept of GMP is – Do as you have written (i.e. SOPs) and write what you have done ( i.e. RECORDS) RECORDS
  9. 9.  The finished product must contain ingredients complying with qualitative and quantitative composition of the product described in the marketing authorization, the ingredients must be of required purity, in their proper containers and correctly labeled. FINISHED PRODUCT
  10. 10. Batch inspection and relevant sampling
  11. 11.  Sufficient samples of starting materials and products should be retained to permit further examination of the product if necessary; the retained samples must be kept in the final pack unless the pack is exceptionally large. RETAINED SAMPLES
  12. 12. 1. Establish, validate and implement all the quality control procedures, maintain sufficient standards and reagents 4. Assess production conditions and IPQAC results. 7. Assess the finished product after evaluation. 2. Evaluate, maintain and store references and working standards for substances. 5. Participate in the investigation of complaints related to quality of the product. 8. Assess manufacturing and packaging documentation. 3. Ensure the correct labeling of containers, materials and products. 6. Participate in the environment monitoring. 9. Compliance with specification of the finished product and examination of final pack. OTHER ACTIVITES OF QC
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Quality control in pharmaceutical Industry


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