QAS-033 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 540

SOP No. QAS-033.00 Effective date: mm/dd/yyyy
Approved by:

52.4.13 P age
In the space for “page,” write the page number, for example, if the total pages is 5, write 1 of 5, 2 of
5, 3 of 5, 4 of 5, 5 of 5 in the ascending order.

52.4.14 e ffective d ate
The date will be provided by the QA manager after the validation and training of SOP by the con-
cerned SOP writer. The effective date will be stamped only on the first page in the space provided.

52.4.15 SoP w riting /c hecking and a PProval
Each SOP will be written by the concerned employee and will be checked by the departmental
manager before final approval by the QA manager.

52.4.16 SoP w rite - uP , r eview , and a PProval
It is the responsibility of all the concerned departmental managers to organize the writing of the
related standard operating procedure and follow a fixed format as per the ABC Pharmaceutical
Company's policy. All SOPs shall be counterchecked by the second person to verify the accuracy of
the contents. All SOPs shall be approved by the QA manager.

52.4.17 SoP t raining e valuation /SoP i imPlementation (e ffective d ate )
After the QA approval, the master SOP will be copied by the QA manager and stamped as “uncon-
trolled copy” (in red color) to be forwarded to the SOP trainer accompanied with the standard
operating procedure validation/training record form (Attachment 1) and SOP evaluation question-
naire for the systems only. The fixed SOP shall be subjected to training through SOP reading and
on-site demonstration (e.g., Attachment 2).

52.4.18 SoP t raining e valuation Q ueStionnaire
It is the responsibility of the SOP writer to prepare the SOP training questionnaire for each SOP and
forward it to the QA manager (e.g., Attachment 2) at the time of first initiation and on consecutive
revisions.

Uncontrolled Copy

For Training Only

Signature: ___________ Date: ________

The trainer will return the uncontrolled SOP with the executed training record form along with the
evaluation questionnaire within 5 working days back to the QA manager.

52.4.19 SoP d iStriBution

1. The QA manager will attach the documented training record form and SOP evaluation
questionnaire with the master SOP and stamp the effective date on the space provided in
the front page of each SOP and the next review date, respectively.