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Responsibilities of Quality Assurance Department

  • OBJECTIVE :To lay down the responsibilities of  Quality Assurance Department.
  • RESPONSIBILITY :
  • All personnel of Quality Assurance Department.
  •  Head of Quality Assurance Department to ensure compliance.
  • Master formula Thiamine Mono-Nitrate,Riboflavine and Pyridoxine Hydrochloride Capsules (drugsformulations.com)

  • PROCEDURE :
  • Quality  Assurance  department  shall   be  responsible to formulate systems for the implementation of cGMP and, to ensure the preparation, approval and implementation  of  Standard   Operating   Procedures, Standard  Cleaning Procedures, Specifications, Standard Test Procedures, Cleaning validation protocols, stability protocols, Master Batch Production records, etc.,
  • Quality  Assurance department shall be responsible for evaluation and qualification of vendors of raw material and packaging material.
  • Quality Assurance department shall be responsible for sampling of raw / packing materials, inprocess materials, finished products and stability samples.
  • Quality  Assurance department shall be responsible to review and approve validation protocols, to review changes in product processes, equipments,or any other changes as per SOP “Change Control programme”.
  • Quality  Assurance department shall be responsible to check dispensing of materials and for inprocess quality control.
  • Quality  Assurance  department  shall  be responsible to release the batch after reviewing  the Batch Production records to assure that the batch has been manufactured as per the Master Batch Production Record and there are no deviations and deviations, if any, are recorded and authorized.
  • Quality  Assurance department shall be responsible for auditing methods,results, systems and processes and for performing the trend analysis and preparation of annual review of drug product quality.
  • Quality  Assurance department  shall  be responsible to release the finished products and to maintain the reserve samples of finished product and batch production and control records.
  • Quality  Assurance department shall be responsible to investigate market complaints and to maintain market complaints investigation records.
  • Quality Assurance department shall be responsible for issue, control, review and retrieval of worksheets.
  • Quality Assurance department shall be responsible for disposition of Incidents/OOS and approval of deviations.
  • Quality Assurance department shall be responsible for monitoring of stability studies.
  • Quality  Assurance personnel shall be trained as per the SOP “Training and Evaluation of Quality Assurance Officers”.
  • Forms and Records
    • NA
  • Distribution
    • Master Copy – Documentation Cell (Quality Assurance)
    • Controlled Copies – Quality Control, Production, Stores, Engineering
  • History
Date Revision Number Reason for Revision
00 New SOP

 

MASTER FORMULA OF AMOXYCILLIN CAPSULES IP (drugsformulations.com)

 

 

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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