GENTRY PHARMACEUTICALS LTD.

Vangnahati, Sreepur, Gazipur.

QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE
Document Title Collection, Storage and Control of Reserve Samples for Drug Products

SOP No.: SOP/QC/001 Revision No. 01 Superseded No.: 01

Issue Date 01.01.2019 Effective Date: 10.01. 2019 Review Date: 01.01. 2022

Prepared by Checked by Approved by

Sign. & Date

Name Abdulla Al-Mamun Md. Kamrul Islam Mohammed Belal Uddin

Designation Sr. Quality Assurance Officer Quality Control Manager Quality Assurance Manager

CONTENT
1. Objective
2. Scope
3. Responsibility
4. Accountability
5. Procedure
6. Distribution List
7. Revision History

1.0 OBJECTIVE:

To lay down a procedure for collection, storage, retrieval and disposition of reserve samples of drug
products.

2.0 SCOPE

This SOP shall be applicable to concern department in Gentry Pharmaceuticals Ltd.

3.0 RESPONSIBILITY:

Quality Assurance Officer for collection, storage, retrieval and disposal of reserve samples.
Head of Quality Assurance Department to ensure compliance.

4.0 ACCOUNTABILITY

Quality Assurance Manager

WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER

DELEGATE, COPY OF THIS DOCUMENT IS STRICTLY PROHIBITED Page 1 of 4
 GENTRY PHARMACEUTICALS LTD.
Vangnahati, Sreepur, Gazipur.

QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE
Document Title Collection, Storage and Control of Reserve Samples for Drug Products

SOP No.: SOP/QC/001 Revision No. 01 Superseded No.: 01

Issue Date 01.01.2019 Effective Date: 10.01. 2019 Review Date: 01.01. 2022

Prepared by Checked by Approved by

Sign. & Date

Name Abdulla Al-Mamun Md. Kamrul Islam Mohammed Belal Uddin

Designation Sr. Quality Assurance Officer Quality Control Manager Quality Assurance Manager

5.0 PROCEDURE:

Every batch/lot of each drug product in all forms of its packing shall be sampled for reserve sample
separately.

During the primary packing of drug product the concerned QA Officer shall collect reserve samples that are
representative of batch of drug product. The reserve sample shall be collected at equal intervals throughout
primary
packing operation of the batch.

The quantity of reserve samples should be at least twice the quantity necessary to perform all the required
tests.

The reserve samples shall be stored in the same immediate container-closure system in which the drug
product is to be marketed.

The reserve samples shall be stored under conditions consistent with the product labeling.

If the drug products are bulk packed, then the reserve samples shall be kept in the same type of packing
like that of bulk packing but in small scale.

The Officer-QA shall enter the details in “Reserve sample register” for drug products.

For all drug products, the reserve samples shall be retained for not less than one year after the expiration
date of the drug product.

For drug product that is exempted from bearing an expiration date, the reserve sample must be retained for
not less than 3 years after the batch of the drug product is distributed.

WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER

DELEGATE, COPY OF THIS DOCUMENT IS STRICTLY PROHIBITED Page 2 of 4
 GENTRY PHARMACEUTICALS LTD.
Vangnahati, Sreepur, Gazipur.

QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE
Document Title Collection, Storage and Control of Reserve Samples for Drug Products

SOP No.: SOP/QC/001 Revision No. 01 Superseded No.: 01

Issue Date 01.01.2019 Effective Date: 10.01. 2019 Review Date: 01.01. 2022

Prepared by Checked by Approved by

Sign. & Date

Name Abdulla Al-Mamun Md. Kamrul Islam Mohammed Belal Uddin

Designation Sr. Quality Assurance Officer Quality Control Manager Quality Assurance Manager

Reserve samples shall be examined visually at least once a year for all commercial batches for evidence of
deterioration, unless visual examination would affect the integrity of the reserve samples (containers).

The results of periodic examination of reserve samples shall be recorded with other stability data of drug
product.

Any evidence of reserve sample deterioration shall be investigated and documented.

At least one packed unit from each lot is to remain unopened in the event chemical testing has to be
performed.

In case of retrieval of any reserve sample the concerned personnel shall fill the “Reserve sample issue
request” and get the approval from Head of Quality Assurance Department Officer-QA shall issue the drug
product requested and fill the request

After the completion of retention period, the concerned Officer-QA shall destroy the sample by incinerating
and enter the disposed o􀃗 date and signature in the reserve sample register for drug products.

6.0. DISTRIBUTION LIST

Department Master/Control Copy No. of Copy Received By (Signature & Date)

Quality Assurance Master & Control Copy 02

Quality Control Control Copy 01

WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER

DELEGATE, COPY OF THIS DOCUMENT IS STRICTLY PROHIBITED Page 3 of 4
 GENTRY PHARMACEUTICALS LTD.
Vangnahati, Sreepur, Gazipur.

QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE
Document Title Collection, Storage and Control of Reserve Samples for Drug Products

SOP No.: SOP/QC/001 Revision No. 01 Superseded No.: 01

Issue Date 01.01.2019 Effective Date: 10.01. 2019 Review Date: 01.01. 2022

Prepared by Checked by Approved by

Sign. & Date

Name Abdulla Al-Mamun Md. Kamrul Islam Mohammed Belal Uddin

Designation Sr. Quality Assurance Officer Quality Control Manager Quality Assurance Manager

7.0 Revision History

SOP No Version No Date Reason of Revision

To set the details proper guideline and new initiated for

SOP/QC/001 01 01.01.2019 Collection, Storage and Control of Reserve Samples for
Drug Products.

WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER

DELEGATE, COPY OF THIS DOCUMENT IS STRICTLY PROHIBITED Page 4 of 4