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✓ Reviewed by: Pankaj Sharma - Quality Control Specialist
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📅 Last Updated: October 24, 2026
SOP on withdrawal, storage, observation & destruction of control sample says you withdraw control samples from each batch under manufacturing. You store them at a temperature not exceeding 25°C, observe them physically every six months, and destroy them one year after the expiry date.
This SOP on withdrawal, storage, observation & destruction of control sample is a procedure that defines how control samples of finished products and raw material retention samples are withdrawn, stored, physically observed and destroyed in a pharmaceutical formulation plant.
1.0 Objective
To define the procedure for the withdrawal, storage, observation, and destruction of control samples from production (OSD & Injectable) and Quality Control (R.M. Retention) in the pharmaceutical formulation plant.
2.0 Scope
This SOP applies to samples from production (OSD (oral solid dosage) & Injectable) and Quality Control (R.M. Retention) in the pharmaceutical formulation plant. Finished product samples are called control samples. Raw material samples are called retention samples.
3.0 Responsibility
3.1 The Quality Assurance (QA) officer (finished product) and Quality Control (QC) personnel (raw material) are responsible for the implementation of this SOP.
4.0 Accountability
The QA Head shall be accountable for the overall compliance with this SOP.
6.0 Procedure
This section covers how you withdraw, store, observe and destroy control samples. Each step follows in order below.
6.1 Withdrawal of Control Sample
6.1.1 Control samples of drug products shall be withdrawn from each batch of products that is under manufacturing.
6.1.2 The quantity of the sample shall be withdrawn as per Table-I.
| S.No. | Sample | Quantity of Sample Drawn (in Units) |
|---|---|---|
| 01 | Tablets | 200 |
| 02 | Capsules | 200 |
| 03 | Dry Syrup (Bottles) | 44 |
| 04 | Dry Powder injection | 128 |
6.1.3 The QA Officer shall collect the finished product control sample from each batch during the packing operation, according to the quantity mentioned in Table-I. The entry shall be made in the finished product control sample logbook as per Annexure No.-I.
6.1.4 For Raw Material retention samples, the QC personnel shall collect the sample and make the entry in the raw material retention sample logbook as per Annexure No.-II.
6.1.5 Control Sample sticker labels shall be affixed to each pack as per Annexure No.-III.
6.1.6 The control sample shall proportionately represent all different pack sizes in the same batch, including sales and physician samples.
6.1.7 Liquid and solvent are not retained in the control sample room.
6.2 Storage of Control Sample
6.2.1 The control sample shall be stored at a temperature not exceeding 25°C.
6.2.2 Temperature monitoring records of the control sample room shall be maintained as per the “SOP on Monitoring of Temperature and Relative Humidity.”
For mapping of the control sample area, see SOP on Temperature Mapping in RM, PM, FG and Control Sample Area.
6.3 Physical Observation of Control Sample
6.3.1 Physical observation shall be conducted every six months, and the observation records shall be maintained as per Annexure No.-V.
6.3.2 During physical observation, the following points shall be considered, wherever applicable. These are visual checks on the stored pack:
- Appearance/Description
- Packing Quality
- Imprinting
- Overprinting
- Intactness of the package
- Delamination
- Peeling/Motting of coated tablets
6.3.3 If a specific amount of control sample or retention sample is needed for testing or reference purposes, the request must be approved first, in accordance with Annexure No.-IV. Only then shall the sample be provided. Such withdrawals shall be recorded in the ‘Finished Product Control Sample Logbook’ and ‘Raw Material Retention Sample Logbook’ as per Annexure No.-I and Annexure No.-II, respectively.
6.4 Destruction of Control Sample
6.4.1 Control samples and retention samples shall be destroyed after one year from the expiry date. Refer to the ‘SOP on Handling Scrap and Disposal‘ for the destruction process.
6.4.2 Destruction records of finished product control samples and raw material retention samples shall be maintained in the ‘Finished Product Control Sample Logbook’ as per Annexure No.-I and ‘Raw Material Retention Sample Logbook’ as per Annexure No.-II.
7.0 Forms and Records (Annexures)
Annexure-I: Finished Product Control Sample Logbook
Annexure-II: Raw Material Retention Sample Logbook
Annexure-III: Control Sample Sticker Label
Annexure-IV: Control Sample/Retention Sample Requisition Slip
Annexure-V: Physical Observation of Control Sample
Related: Quality Control Test for Secondary Packing Materials, SOP on Storage and Hold Time Study for Products
8.0 Distribution
Master copy: Quality Assurance
Controlled copies: Quality Assurance, Production, Quality Control & Warehouses RM.
5.0 Abbreviations and Definitions
This section explains the short forms and terms used in this SOP.
SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control
OSD: Oral Solid Dosage
R.M.: Raw Material
Control sample: the finished product sample that the QA officer collects from each batch during the packing operation.
Retention sample: the raw material sample that the QC personnel collect.
Annexure-I: Finished Product Control Sample Logbook
| Batch No. | Product Name | Date of Sample Withdrawal | Quantity Drawn (Units) | Remarks |
Annexure-II: Raw Material Retention Sample Logbook
| Batch No. | Raw Material Name | Date of Sample Collection | Quantity Drawn (g/kg) | Remarks |
Annexure-III: Control Sample Sticker Label
Annexure-IV: Control Sample/Retention Sample Requisition Slip
| Requested By | Date of Request | Purpose of Request | Quantity Requested (Units/g/kg) | Approved By | Date of Approval |
Annexure-V: Physical Observation of Control Sample
| Batch No. | Product Name | Date of Observation | Observations | Remarks |
Frequently Asked Questions
Control samples shall be stored at a temperature not exceeding 25°C (step 6.2.1). Temperature monitoring records of the control sample room shall be maintained as per the “SOP on Monitoring of Temperature and Relative Humidity” (step 6.2.2). For mapping of the area, the related temperature mapping SOP is linked under clause 6.2.2.
Physical observation shall be conducted every six months. The observation records shall be maintained as per Annexure No.-V, the Physical Observation of Control Sample form (clause 6.3.1). You record each observation there so the history of the stored samples stays complete.
Control samples and retention samples shall be destroyed after one year from the expiry date (clause 6.4.1). The destruction process follows the SOP on Handling Scrap and Disposal. The destruction is then recorded in the relevant logbook (clause 6.4.2).
During physical observation, you look at appearance/description, packing quality, imprinting, overprinting, intactness of the package, delamination, and peeling/motting of coated tablets, wherever applicable (clause 6.3.2). These are the points the SOP lists for every stored sample.
Five annexures support this SOP: the Finished Product Control Sample Logbook (I), the Raw Material Retention Sample Logbook (II), the sticker label for control samples (III), the requisition form (IV) and the Physical Observation of Control Sample record (V). Withdrawals and destruction are entered in logbooks I and II.
No. Liquid and solvent are not retained in the control sample room (clause 6.1.7). The control sample room holds the finished product control samples and the raw material retention samples described in clauses 6.1.3 and 6.1.4, kept at 25°C or below.
The QA officer collects the finished product control sample from each batch during the packing operation and makes the entry in the finished product control sample logbook (clause 6.1.3). The QC personnel collect the raw material retention samples and enter them in the raw material retention sample logbook (clause 6.1.4).
Pankaj Sharma — Quality Control Specialist
Pankaj Sharma is a pharmaceutical QC professional who reviews our technical content for GMP accuracy, laboratory practices, and regulatory relevance.