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
Pharmaceutical Plant requires following records pertaining to different activities to be maintained.
- Production Records
- Quality Control Records
- Inventory and Store Records
- Utility and Maintenance Records
- Administrative Records
A suitable and definite procedure is followed for the above record keeping’s. The procedure includes the following steps.
- Opening the record keeping Registers/proformas.
- Data Entry.
- Issue of the Registers/Proformas for use.
- Withdrawal of the Registers/Proformas.
Method of Record Keeping:
- The format as per the Drug Act or any other prevail Act or Rule is drawn on the register for individual cases/activities.
- The Concerned Person is intimated and the Record Register/Proforma is handed over to him.
- The record is being kept periodically as required by the Practice/Rule/Law.
- They are checked regularly by Supervisions/Section In-charges/HODS.
- The data entry is done regularly as per the requirement.
- All the entry should specify date of entry, content, signature etc.
- The concerned Supervisors check each entry for completeness.
- The registers are issued from time to time only on completion of the previous ones.
- When the format is changed due to change of Act/Rule/Custom, the Registers/Proformas are changed.
- A record is kept for all these issue and withdrawal of Registers/Proformas.
- A Register/Proforma is withdrawn only in completion of all pages and/or at the time of changes of format.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)