PHARMA DEVILS

QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Finished Product Control Sample Collection, Storage and Disposal Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:
1.0 OBJECTIVE:
To lay down a procedure for finished product control sample collection, storage and
disposal.

2.0 SCOPE:
The procedure is applicable to the finished product samples required for control sample
collection, storage and disposal.

3.0 RESPONSIBILITY:
Executive/Officers – Quality Assurance, Quality Control
Head – Quality Assurance

4.0 DEFINITION(S):
NA

5.0 PROCEDURE:
5.1 Collection and Storage of Control Samples:
5.1.1 Withdraw control sample from each batch for all products (Refer Annexure-II) from start,
middle and end of the packing operation.
5.1.2 If there is more than one type of packing of same batch, withdraw the control sample for all
types of packing.
5.1.3 Quantity specified for the sampling is based on the requirement of a minimum of two
complete analysis.
5.1.5 Withdraw the required number of blisters / strips and arrange to place in control sample
room in the specified rack/location.
5.1.6 Put the control sample stamp on the outer side of each pack with red colour ink and record
the detail in control sample register as per Annexure –III.
5.1.7 Lock the control sample room and keep the key under the custody of Head-QA.
5.1.8 Control sample shall be stored for a period of 12 months beyond the expiry date of the
product.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Finished Product Control Sample Collection, Storage and Disposal Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:
5.1.9 Control samples shall only be removed out from control sample room incase of unavoidable
circumstances like re-analysis for market complaint and shall be removed out after written
approval of Head-QA.
5.1.10 Requisition for the control samples removed out/used for analysis shall be stored in file as a
record.
5.1.11 Record the temperature and relative humidity of the control samples room twice in a day
using a calibrated hygrometer as per Annexure –I.
5.1.12 The temperature shall be 25 ± 2°C and relative humidity within 50 ± 5 %.
5.1.13 Incase temperature and relative humidity goes beyond the limit, inform to maintenance
department immediately to rectify the problem.
5.1.14 Evaluate the control sample every six months for physical appearance and shall be recorded
as per Annexure –IV.
5.1.15 In case of physical discrepancy, sample shall be subjected for complete analysis as per
product specifications.
5.2 Destruction of control Samples:
5.2.1 After completion of storage period, segregate the control samples and label them as “Control
Samples For Destruction”.
5.2.2 Get the approval from QA-Head for destruction of Control Samples.
5.2.3 Defoil the strips / blisters and dissolve it into water and transfer the disposals into ETP and
also transfer the empty strips / blisters into scrap yard for destruction.
5.2.4 Record the destruction of control samples as per Annexure –III

6.0 ABBREVIATION(S):
QA : Quality Assurance
ETP: Effluent Treatment Plant.

7.0 REFERENCE(S):
NA

8.0 ANNEXURE(S):
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Finished Product Control Sample Collection, Storage and Disposal Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:
Annexure – I: Temperature and Relative Humidity Record
Annexure – II: Control Sample Quantity
Annexure – III: Control Sample Register
Annexure – IV: Control Sample Observation Record.

9.0 REVISION CARD:

S.No. REVISION No. REVISION DETAILS OF REASON (S) FOR
DATE REVISION REVISION
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Finished Product Control Sample Collection, Storage and Disposal Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:
Annexure I

TEMPERATURE AND RELATIVE HUMIDITY RECORD

(CONTROL SAMPLE ROOM)

Frequency : Twice a day

Temperature : 25±2°C Month/Year:
Relative Humidity : 50±5%

Date Time Temperature (0C) Relative Humidity Checked By

(%)
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Finished Product Control Sample Collection, Storage and Disposal Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:
Annexure II
Control Sample Quantity

S.No. PRODUCT QUANTITY

PHYSIAN SALE EXPORT
SAMPLE
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Finished Product Control Sample Collection, Storage and Disposal Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:
Annexure III
CONTROL SAMPLE REGISTER
Product Name:
S.No. Date B. No. Mfg. Exp. Quantity Quantity Purpose Authorization Date of Destroyed Remark
Date Date withdrawn Destruction By/Date
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Finished Product Control Sample Collection, Storage and Disposal Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:
Annexure IV

CONTROL SAMPLE OBSERVATION RECORD

Product Name Pack Style

Batch No. Mfg. Date Exp. Date

Initial Description

Description
S.No. Date Checked By/Date
(Complies/Does not Complies)