QCS-006 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 14

SOP No. QCS-006.00 Effective date: mm/dd/yyyy
Approved by:

6.1 PurPose
To provide written instructions for recording the analysis and controlling analytical registers and
records (journals, reports, and analysts log books).

6.2 resPonsibility
It is the responsibility of the sample receiving officer and analysts to follow up the procedure. The
QC manager/director will be responsible for the SOP compliance.

6.3 Procedure

1. Sample receiving registers

1.1 Data on the received samples of raw and packaging material and the bulk and finished
products are entered in their respective registers and the QC sample results are entered
in the QC module by the sample receiving officer. After assigning a QC number the
samples are distributed as per the procedure.

1.2 The above-mentioned registers are used upto the last page and on completion they are
labeled with starting and ending QC numbers including the respective dates and are
archived.

2. Analysts registers

2.1 Registers of raw and packaging materials as well as bulk and finished products analy-
sis are maintained with each analyst of the respective section for entering the raw data
of analysis.

2.2 These registers are controlled by assigning a serial number for each one at the time of
issuance.

2.3 Completed registers are serially labeled by the user and returned to the corresponding
section supervisor/incharge who then maintains them in an archive.

3. Analytical reports

3.1 The raw material reports after final review by a supervisor and counter signed by a QC
manager/director are filed in the corresponding records meant for raw material accord-
ing to the code number.

3.2 Bulk and finished product reports are filed with their respective batch files.

3.3 Packaging material reports are filed in alphabetical order and stored in an archive.

4. Recording the analysis

While recording the analysis, the analyst must consider and record the following:

a. Identification of the instrument

b. Preparation of diluent

c. Standards traceability

d. Lot number of working standard used

e. Mobile phases

f. Test solution

g. Recording of calculations pertaining to the test with representative units of measurement

h. Documentation of media used for microbiological testing

6.4 reason for revision
First time issued for the ABC Pharmaceutical Company.