Control Sample Management in Pharmaceuticals

What is Control Sample:

An appropriately identified sample that is representative of each batch that shall be retained is known as control sample. These are also referred as retention or reserve sample.

Control samples shall be collected for Finished Product, Raw Material and Packing Materials.

Why Control Sample shall be collected:

As per regulatory and Customer requirements.

To perform Analysis in case of investigation or failure.

To perform investigation in case of market compliant.

For any additional testing if required 

Control sample shall be collected for fresh Raw & packing materials which are received at warehouse and for finished products it shall be collected for each batch, (commercial, Validation and optimization) market order and each type of pack style.

Sampling and storage of control samples (Raw materials, Packing materials & Finished Products) :

The quantity of reserve or control samples shall be collected at least twice the quantity necessary to perform complete analysis and same shall be entered in the control sample Register.

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

The control samples shall be stored under conditions as mentioned on the product label or store below 25°C.

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

Active Pharmaceutical Ingredients for which the manufacturer provides the date of expiry the control sample shall be stored for 1 Year after the expiry date. In case of excipients control sample shall be retained for 5 Years from the date of sampling.

Exhibit batch shall be stored up to the regulatory approval.

In case of withdrawal of control sample for investigation purpose the control sample issuance request form to be filled and same must be entered in the control sample record with appropriate reason.

Review of Finished product control samples:

 Control samples of all pack types of all batches and of products shall be examined visually at least once a year for evidence of product quality attributes & same shall be recorded.

Any evidence of reserve samples deterioration shall be investigated and necessary Corrective action and preventive action shall be taken.

Ten Tablets / Capsules shall be used for each visual inspection and shall be discarded.

 In case of Dry Syrup, One unit pack shall be used for each visual inspection and shall be discarded and in case of bottle pack control sample pack shall be re-sealed after visual inspection.

After withdrawal of sample for periodic review, balance quantity of batch shall updated in control sample record.

Destruction of Control Sample:

Every month Quality Assurance & Quality Control persons shall review the control register if any sample crossed the retention period.

Control samples of raw & packing materials and finished products shall be taken for destruction separately.

Quantity of control samples destroyed shall be entered in control sample register and same shall be checked by & verified by other persons.

For Destruction of Control Samples suspend them in a half filled container of water until the powder, tablets and the content of capsules are dispersed. Transfer the sample to be disposed into a plastic bucket containing 2 % NaOH Solution, make Slurry and the transfer into a polybag & send for destruction.

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