Monday , September 25 2023

Document Management System in Quality Assurance Department in Pharma Industry

Document Management System in Quality Assurance Department

Standard Operating Procedure (SOP)

  • Objective:
    • To lay down a procedure for Management of Documents in Quality Assurance Department in Pharma Industry
  • Scope:
    • Applicable for Document Management system in Quality Assurance department.
  • Responsibility:
    • Quality Assurance Department
  • Accountability:
    • Head- QA shall be accountable for compliance of this SOP.
  • Procedure:
    • Storage of Documents in Record Room in Pharma Industry.
      • Documents shall be stored in record room compactor.
      • The Record room contains 5 Compactors which has been marked as C1 to C5.Each compactor have 20 racks, except the Compactor number 1 and compactor number 5, which contains 10 racks each.
      • The Racks have been given the rack number of 5 digits. For example Rack number “C2 R15” where, first two digits “C2” represents the Compactor number 2 and last two digits represents the rack 15 in compactor.
      • The document which is to be stored in the compactor shall be checked and verified by the QA personnel.
      • The document will be assigned to particular Rack in a particular Compactor.
      • Master List of documents which are kept in the compactor will be maintained by QA.
      • Index for each compactor shall be maintained . Copy of Index for each compactor shall be pasted on each compactor.
      • Master List and Index for each compactor shall be updated immediately after the addition or removal of documents from the compactor.
      • In case any document is required, same shall be issued and recorded .
    • Storage of Documents in QA Department in Pharma Industry.
      • All the documents which have been approved and mastered shall be kept under lock and key and shall only be accessible to authorized person of QA.
      • Documents shall be kept in the files having the file number starting from 01 onwards as the sequences increases.
      • All the files except the files containing STPs / GTPs / Specification / SOPs must have the Index on the first page of the file .
      • Files containing the documents can be kept in the 6 Almirah’s which has been numbered from A1 to A6 and the shelf shall be labeled as S1, S2, and S3 …..onwards.
      • Index for the documents in each Almirah shall be pasted on the back side of the door of Almirah mentioning the file number and the shelf number.
      • Master List of all the documents shall be maintained .Master list of documents shall be updated quarterly and in between changes can be done manually on the master list.
      • No document shall be kept without file and no master document shall be kept in the personal drawers for any reason.
    • Issuance of Master and other documents for reference purpose in Pharma Industry.
      • Documents shall be issued for reference purpose.
    • Storage of other Documents and samples in QA Department in Pharma Industry
      • Other things like COAs, Logbooks, worksheets, reference samples, party samples, and stationary can be kept in the Racks with locks numbered as R01 to R02
      • Every rack shall be dedicated to only one type of item only.
      • Rack shall be labeled with the name of the items on it.
      • List of items and the control of items can be maintained in the in house format.

List of Annexure / Formats:

S. No. Format Title
1 Master List of Documents
2 Index of Documents
3 Documents Issuance record
4 File Index
5 Almirah Index

References (If any):

  • Not Applicable

Reason for Revision:

  • Periodic revision.

Abbreviation & Definition:

QA:  Quality Assurance

SOP: Standard Operating Procedure

STPs: Standard Test Procedure

GTPs: General Test Procedure







About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 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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