The objective of this Standard Operating Procedure (SOP) is to lay down a procedure for handling, storage and destruction of control samples of Raw material.
This SOP is applicable to Control samples of all raw material in Quality Control Department at manufacturing facility.
- Analyst / Section Head or his designee shall be responsible for collection of control sample.
- The Head of Quality Control Department or his designee shall be responsible and implementation of the SOP.
- Control samples shall be collected during sampling as per the “Procedure for sampling of
Raw materials & periodic verification of CEP status of CEP grade materials” SOP No.
QC011. Sufficient quantities (as defined in respective specification) shall be kept to conduct
at least two full specification analyses.
- The Control samples shall be kept only for approved batches.
- Keep the samples according to its recommended storage condition in the designated room. Record the temperature and related humidity twice in a day.
- The Control sample shall be stored in the double lined poly bag in fiber board drum.
- Prepare the two packs equal quantity and each pack shall be numbered as 1/2 and 2/2 and shall be written on label.
- Affix the “Control Sample” label on the packs as per Annexure I
- All the packs shall be transferred in the mini pack and this mini pack shall be labeled.
- After completion of analysis and release the material, Control sample shall be kept in the Control sample room. The Control sample of Empty Hard gelatin capsule shall be stored in dedicated area of Raw material store III with proper segregation.
- Control sample shall be kept month wise in plastics tray.
- In-case of failure of the batch, the Control sample shall be disposed after closure the “Out of Specification” and the sample shall be disposed.
- Make the entry of Control sample in “Control Sample storage record” as per Annexure II.
- In case of require to withdraw of control sample, Analyst shall withdraw the sample from first pack i.e. 1/2 .If required sample quantity not sufficient in the 1/2 pack, then sample shall be removed from 2/2 pack.
- Mention the balance quantity on its place and record it in the Format as per Annexure II.
- The Raw material Control samples shall be retained for Expiry + 1 Year.
- Authorized QC designee shall ensure the preservation period of control sample.
- Authorized QA personnel shall ensure the environment condition of control sample room & shall record the temperature & humidity twice in a day according to limit specified in SOP (QA038)
- Authorized QA personnel shall record the Min/Max temperature & humidity in format (F/ QA038/03 according to limit specified in SOP (QA038).
- Removal of Control Samples from Control Sample Room
- If control samples are required to be removed from control sample room for any Specific purpose, concerned department shall raise a requisition as per Annexure III .
- mentioning the Reason and quantity required in the requisition form.
- Requisition form shall be authorized by QA head.
- After authorization by QA head, QA personnel shall remove the required quantity and record the same in the control sample log book refer Annexure II
- Destruction of Control Samples
- Authorized designee of QC Dept. shall prepare the list on monthly basis for destruction of expired control samples as per Annexure IV
- List of control samples prepared by QC personnel for destruction shall be checked by another authorized designee of QC Dept. and authorized by QA Head.
- QC department shall maintain record of destruction of control samples and update the control sample log book refers Annexure II
- Destruction shall be carried out by soaking in sufficient water or crushed into powder with the help of roller and burnt in a pit.
- Secondary and primary packaging material destroyed by shredding and burning in a pit.
- TRAINING :
Trainer : Head – Quality Control
Trainees : Quality Control chemist / Sectional Heads
- DISTRIBUTION :
Controlled Copy No. 1 : Head of Department – Quality Assurance
Controlled Copy No. 2 : Head of Department – Quality Control
Original Copy : Head – Quality Assurance
Annexure-I : Labels for Control Sample
Annexure-II : Control Sample storage record
Annexure-III : Requisition Form for Control Sample Withdrawal
Annexure-IV : Destruction Report of Control Samples
- 9.REVISION HISTORY:
|Sr. No.||Revision No.||Change Control Number||Details of Revision||Reasons (s) for Revision|
|1||00||—-||New SOP||New SOP|