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Document Maintenance�( Quality audit, Quality review, Quality documentation & Distribution records)

DEPARTMENT OF PHARMACEUTICAL SCIENCES & TECHNOLOGY

PHARMACEUTICAL QUALITY ASSURANCE

BIRLA INSTITUTE OF TECHNOLOGY, MESRA

RANCHI-835215

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LEARNING OUTCOMES

  • Upon completion of this video, we will be able to,
  • Know what is document maintenance
  • Know some important terms like quality, audit, documentation.

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CONTENTS

  • QUALITY AUDIT
  • QUALITY REVIEW
  • QUALITY DOCUMENTATION
  • DISTRIBUTION RECORDS

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QUALITY AUDIT

  • Quality audit – it is a standard monitoring process that ensures proper assessment of a system, adequate implementation of processes, elimination of problem areas, and boosting the efficiency of methods.
  • Quality audit is considered an integral part of the quality management system and is considered as a critical component in the ISO quality system standard ISO 9001.

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TYPES OF AUDIT

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QUALITY REVIEW

  • Process of reviewing all specifications at all in process check point are met and all documentation with signatures are incorporated in batch record.
  • Product Quality Review (PQR) is a mechanism to ensure that data captured by the Pharmaceutical Quality System (PQS) is reviewed for trends. This tool can support a continuous improvement environment.
  • PQRs are designed for the purpose of identifying and implementing recommendations for required improvements.

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LET’S RECALL

  • What do mean by quality audit.
  • What is quality review.

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QUALITY DOCUMENTATION

  • Document is a paper providing information especially of an official or legal nature, written report.
  • Quality documentation – is any communicable material that is used to describe, explain or instruct regarding some attributes of an system.
  • This documents comprises of –
  • Quality policy
  • Quality procedures
  • Work instruction
  • Records

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DISTRIBUTION RECORDS

  • They are written data related to distribution of drug products from manufacturer to distributors.
  • It shall contains –
  • Name & strength of products
  • Description of dosage form.
  • Name & address of cosigner
  • Date & shipped quantity
  • Lot & control number of drugs

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THANK YOU

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Prepared by-

Kaviren kumar Arya, m pharm, 2nd Year,

Pharmaceutical Quality assurance

Department of pharmaceutical sciences & technology

Birla institute of technology, mesra, ranchi