Standard Operating Procedure For Record Keeping

by Pharmadocx Consultants

PURPOSE:    To lay down a procedure to maintain the records used in different activities.

SCOPE: This procedure applies to all types of records maintained in the company.

RESPONSIBILITY  :          Supervisors

Section In-charges


Pharmaceutical Plant requires following records pertaining to different activities to be maintained.

  1. Production Records
  2. Quality Control Records
  3. Inventory and Store Records
  4. Utility and  Maintenance Records
  5. Administrative  Records

A suitable and definite procedure is followed for the above record keeping’s.  The procedure includes the following steps.

  1. Opening the record keeping Registers/proformas.
  2. Data Entry.
  3. Issue of the Registers/Proformas for use.
  4. Withdrawal of the Registers/Proformas.

Method of Record Keeping:

  1. The format as per the Drug Act or any other prevail Act or Rule is drawn on the register for individual cases/activities.
  2. The Concerned Person is intimated and the Record Register/Proforma is handed over to him.
  3. The record is being kept periodically as required by the Practice/Rule/Law.
  4. They are checked regularly by Supervisions/Section In-charges/HODS.
  5. The data entry is done regularly as per the requirement.
  6. All the entry should specify date of entry, content, signature etc.
  7. The concerned Supervisors check each entry for completeness.
  8. The registers are issued from time to time only on completion of the previous ones.
  9. When the format is changed due to change of Act/Rule/Custom, the Registers/Proformas are changed.
  10. A record is kept for all these issue and withdrawal of Registers/Proformas.
  11. A Register/Proforma is withdrawn only in completion of all pages and/or at the time of changes of format.

The Record of issue and withdrawal is maintained in the following format:

Author: (GM Production)Checked by: (QC Manager)Authorised by: (Director Technical)
Date:Date :Date :

(Review date on or before 12 months from date of authorization)

Written by Anmol Singh

Anmol Singh Completed his Bachelors in Field of Mechanical and Automation Engineering. He has over 2 Years of experience in field of Pharmaceuticals, Medical Devices, Cosmetics Manufacturing.

13 June 2023

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