QAS-033 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 542

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

For example:

• Equipment operating procedures
• Calibration procedures
• Maintenance procedures
• Cleaning procedures
• Housekeeping procedures

52.4.24 o ngoing SoP r eviSion

1. The system-related SOPs and fixed SOPs can also be subject to review based on the com-
ments from the end users, cGMP requirements, changes in hardware and software, com-
ments from the internal and external auditors that shall follow change control SOP
No.

.

52.4.25 d iSPlay SoP S
The SOPs on display or location will be marked in the “distributed to” space as given below:

1. Production department/stores/weighing area, for example:

a. Room No. 1 = R1 (DISPLAY)

b. Room No. 1 and 2 = R1 and 2 (DISPLAY)

c. Room No. 1 to 10 = R1-10 (DISPLAY)

2. Packaging department, for example:

a. Line No. 1 = L1 (DISPLAY)

b. Line No. 1 and 2 = L1 and 2 (DISPLAY)

c. Line No. 1 to 14 = L1-14 (DISPLAY)

3. Quality control, for example:

a. Microbiological laboratory = Micro. Lab.

b. Physical laboratory = Phy. Lab.

c. Chemical laboratory = Chem. Lab.

d. Instrumental laboratory = Inst. Lab.

4. Product development lab, for example:

a. Formulation

b. Stability

c. HPLC

d. Mfg.

5. Maintenance, for example:

a. Equipment operating procedures (as appropriate) on display in departments will be

marked as (DISPLAY).

6. The SOP displayed at all places or lines will be marked as DISPLAY. All SOPs on display
will also be logged in the SOP distribution record register (Attachment 3).