QAS-029 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 412

SOP No. QAS-029.00 Effective date: mm/dd/yyyy
Approved by:

Subject: Technical Documents Distribution Control

48.1 PurPose
The purpose of this SOP is to describe the procedure for the distribution of technical documents in
the ABC Pharmaceutical Company.

48.2 resPonsibility
It is the responsibility of all departmental managers to follow the procedure. The assistant manager
systems is responsible for the SOP compliance.

48.3 Procedure

1. All original technical documents of the company will be kept under the control of the
systems department and the PDL.

2. The technical documents are considered level 2 documents and cannot be copied by any-
one except the systems department designate.

3. The technical documents include

documents responsible

i. Manufacturing formula and method R&D lab

ii. Finished production specification (FPS) Systems

iii. Standard test method (STM) Systems

iv. Stability report Systems

v. Master packaging instruction (MPI) R&D lab

vi. Packaging material specifications R&D lab

vii. Raw material specification (RM) Systems

viii. Test method validation report Systems

ix. Registration documents Systems

x. In-process control specification (mfg. and pack.) Systems

xi. Raw material purchasing specification R&D lab

xii. Packaging material purchase specification R&D lab

4. All technical documents will have a fixed format describing information such as

i. Written by

iii. Reviewed by or verified by

iii. Checked by

iv. Approved by

5. After approval from the QA director, the master documents will be handed over to the
systems department designated person by the concerned department through the “docu-
ment update request” form.

6. The systems department designate will make the required number of photocopies as per
the distribution list from the original document and stamp it in red ink as not to be repro-
duced or copied .

7. The manager systems/designate will be responsible for providing the current in use copy to
the related department as per the distribution list.