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:

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

END OF SOP