QCS-013 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 68

SOP No. QCS 013.00 Effective date: mm/dd/yyyy
Approved by:
13.1 PurPose
To provide a stepwise procedure for laboratory analysts to arrange, retain, and assign storage
duration to the packaging materials, raw materials, and finished product reference samples and
monitor the environmental conditions of the reference sample room.
13.2 resPonsibility
1. Manager QC/designate will be responsible for handling the reference samples for raw
material.
2. It is the responsibility of the physical testing lab officer/designate to follow the described
procedure for maintaining and keeping reference samples of finished products.
3. QC packaging officer/designate will be responsible for maintaining the packaging material
reference samples.
4. The physical testing lab officer will be further responsible for monitoring the environmen-
tal conditions of the storage areas for reference samples of raw/packaging materials and
finished products.
5. Manager/director quality control will be responsible for the SOP compliance.
13.3 scoPe
This SOP is applicable to reference samples of all raw and packaging materials and finished products
manufactured and packaged at ABC Pharmaceutical Company as per FDA GMP guidelines,
EU-GMP guideline (Annex. 19), and the requirements of local drug rules.
13.4 Procedure
1. Arrange samples of raw and packaging materials and finished products appropriately
according to the batch number.
2. Keep all samples/products well segregated.
3. Monitor the temperature and the humidity of the room through temperature/humidity
monitoring chart on a daily basis. In case of a deviation, inform the QC manager to call the
maintenance staff for corrective action and implementation.
4. Maintain separate files for temperature and humidity records.
5. After checking the temperature and the humidity, sign the charts with date.
6. Reference samples from each batch of finished products will be retained for at least 1 year
after the expiry date. The raw material reference samples will be retained for 3 years after
the shelf life of the finished product.
7. After the retention period is over, the samples will be destroyed as per site SOP ABC-000.
Note : Room temperature range: 15-25°C; Humidity range: 35-65%.
13.5 reason for revision
First time issued for your company, affiliates, and contract manufacturers.