sop for collection storage and disposal of control samples

1.0 OBJECTIVE:

The objective of this SOP is:
1.1 To describe the procedure for collection, storage and disposal of control samples.

2.0 RESPONSIBILITIES:

2.1 Quality Assurance Officer shall be:

2.1.1 Responsible for collection of control sample of finished products.
2.1.2 Updation of Control Sample Register whenever necessary.

2.2 Quality Control Officer:

2.2.1 Responsible for collection of control sample of Raw Materials.
2.2.2 Responsible for appropriate storage of control samples as per prescribed storage conditions.
2.2.3 Responsible for overall verification of control sample room.
2.2.4 Responsible for visual examination of control samples.
2.2.5 Responsible for preparation of Control Sample Destruction list in the beginning of the month.
2.2.6 Responsible for disposal of control samples as per SOP No.
2.2.7 Updation of Control Sample Register whenever necessary.

3.0 ACCOUNTABILITY:

Head – Quality Assurance

4.0 PROCEDURE:

4.1 Collection and Storage of Control Samples of finished products.

4.1.1 Control samples shall be collected for each batch / market and pack. In case if the batch is packed for sale as well as samples collect the control sample from both the packs.

4.1.2 During the packaging operation In-process Quality Assurance Officer shall collect a Representative sample of intact pack (sample size mentioned in Annexure – 1) and enter in the batch manufacturing record & same shall be written in control sample register.
4.1.3 Quality Control Officer responsible for the maintenance of Control Samples, shall arrange to collect samples from In-process Quality Assurance laboratory and acknowledge the receipt.
4.1.4 Quality Control Officer responsible for collection and maintenance of Control Samples and shall record the details in Control Samples register (Refer Annexure – 2). The Control Samples shall be stored in control sample room.
4.1.5 Control Samples shall be maintained for a period of one year after the expiry of product.

4.2 Collection & storage of Control Samples of Raw Materials:

4.2.1 Quality Control Officer responsible for sampling of raw materials shall sample the raw materials and make Control Samples as per SOP No: “Sampling of raw materials (Non Sterile)” and SOP No: “Sampling of raw materials (Sterile)”.
4.2.2 Control Samples shall not be collected for following items:
Gases
Organic solvents & Corrosive substances (acids / alkali)

4.2.3 Quality Control Officer responsible for maintenance of Control Samples, shall arrange to collect samples from packaging material testing laboratory and acknowledge the receipt.
4.2.4 Quality Control Officer shall be responsible for collection and maintenance of Control Samples and for recording the details in Control Samples register. The Control Samples shall be stored in Control Sample Room.
4.2.5 Control Samples shall be maintained for a period of 2 years after expiry of the product.

4.3 Review of Control Samples:

4.3.1 Control samples shall be visually examined for any abnormality, atleast once in a year and the observation shall be documented in the Visual Inspection record of Control Samples (Refer Annexure –2).

4.4 Disposal
4.4.1 Control Samples shall be destroyed as per destruction procedure mentioned in SOP No.
4.4.2 Update the Record for Destruction (Refer Annexure –2) of control samples.

4.5 Procedure for Destruction:

4.5.1 All finished product / raw material samples of Cephalosporin group of products shall be disposed off after treating with 2%w/v Sodium hydroxide solution.
4.5.2 Finished products (Tablets, capsules, dry syrups & vials (except for Cephalosporin group))
4.5.2.1 Tablets, capsules and powder shall be removed from their respective pack.
4.5.2.2 Packaging Material shall be destroyed by shredding and products shall be destroyed as per the procedure mentioned in SOP No.
4.5.2.3 The content of the ampoule / bottles / liquid vials shall be collected in a container and after adjusting the pH to approximately 7.0 shall be drained into the effluent treatment plant.
4.5.2.4 Ampoules / Bottles / Liquid Vials shall be destroyed by breaking and the packing material shall be destroyed by shredding.

4.6 Raw materials

4.6.1 Raw materials shall be removed from their container. (Except for Cephalosporin group)
4.6.2 The containers shall be destroyed by breaking (in case of glass) or by cutting (in case of plastic).

5.0 REASON FOR REVISION:

This SOP is modified in order to be more effective in its responsibility, incorporation of various records, and schematic diagram (Refer Annexure – 5) for better presentation.

6.0 TRAINING:
Trainer — Head – Quality Assurance
Trainee — Quality Control / Quality Assurance Officers
Period — One day

7.0 DISTRIBUTION:

Certified Copy No. 1 : Head of Department – Quality Control
Certified Copy No. 2 : Head – Plant Operations
Reference Copy No3 : For Display in Control Sample Room
Original Copy : Head – QUALITY ASSURANCE

8.0 ANNEXURE:

Annexure – 1 : List for Control Sample Quantity of Finished Products / Raw Materials
Annexure – 2 : Format for Control Sample Record

9.0 REFERENCE:

In-house