QAS-018 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 328

SOP No. QAS-018.00 Effective date: mm/dd/yyyy
Approved by:

37.1 PurPose
The purpose of this SOP is to provide guidelines for SOP and technical documents handling so as
to maintain the security and control of the documents.

37.2 resPonsibility
The departmental managers are responsible to understand and implement the procedure. The QA
director is responsible for SOP compliance.

37.3 Procedure

37.3.1 d ocument S ecurity and c ontrol
1. Effective date system implemented on the first page for SOP and master manufacturing
formula (MFM).

37.3.1.1 documents

Level 1: Policy-related documents are systematically written, checked, and approved. Only
authorized personnel can make a photocopy for distribution. All records are maintained
appropriately including quality system manual for the company.

Following are the types of documents to be controlled and kept under security. All these
documents are kept under security by the documents controlling section.

i. Manufacturing formula and method R&D

ii. Finished production specification Systems

iii. Standard test method (STM) Systems

iv. Stability report Systems

v. Master packaging formula R&D

vi. Packaging material specifications R&D

vii. Raw material specification (RM) Systems

viii. Test method validation report Systems

ix. Regulatory affairs documents Systems

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

xi. Raw material purchasing specification R&D

xii. Packaging material purchase specification R&D

xiii. MFM R&D

xiv. Any other document of technical nature considered

the property of the company

The formats can be photocopied or reprinted by the departmental managers and forwarded
to the supervisors; however, each format must be signed and dated by the supervisor.

Level 2: SOPs

Note :
• MFM issue for production will be controlled by the QA manager.
• Each planning will send a report to the QA manager.
• After making an entry, the MFM will be issued as a photocopy and the irst page will
be stamped (red) batch No., date, and signature.