1. RESERVE OR RETENTION SAMPLES PRESENTED BY N. SRIKANTH 1

2. Common Names  Reserve samples  Retention samples  Control samples  Reference samples 2

3. Definitions  Reference samples  Starting material or finished product or packing material which can be stored for the future analysis if the need arises during the shelf life of the Batch concerned.  Retention sample:  Sample collected from the batch. These are useful for referring the packing style, batch number, Mfg date, Exp date, Patient leaf let or any other relevant information for the batch concerned during shelf life. 3

4. Sample size and analysis  Samples shall be collected for Starting material, Finished Products and packing materials for each and every batch of the manufacturing.  Samples shall be Collected in such a way that the quantity minimum required for two times full analysis as per compendial analysis or In-house product specification. 4

5. Storage  Active pharmaceutical ingredient (API) and finished product samples shall be stored at their label storage conditions and packing similar to marketed product.  The API and finished products shall be stored in its primary packing material. 5

6. Physical Observation of the samples  Visually inspect the samples for every six months. Record the observations in the register. 6

7. Retention period  Finished Products reserve samples shall be maintained at least for one year after Expiry date (EudraLex, Volume-4, Annexe 19/21 CFR 211.170). Samples of starting material Retain for at least two years after the release of product, it may be shorted if the material shelf life is shorter.(EudraLex, Volume-4, Annexe 19).  For an active ingredient in a drug product the samples shall be retained for 1 year after the expiration date of the last lot of the drug product containing the active ingredient or 3 years from the date of distribution which ever is longer(21 CFR 211.170 Reserve samples). 7

8. Sample Deterioration  Any deterioration observed during inspection or analysis the batch shall be investigated( 21 CFR 211.192(Production record review). 8

9. Destruction  Destroy the samples after retention period. Destruction shall comply as per the regulatory requirements of their country( Solid waste disposal or liquid waster disposal etc..) 9

10. Records  Reserve samples inward register, samples destruction record, Physical observation record shall be maintained by Quality Control department. These registers shall be maintained for both API and Finished Products.  Reserve samples inward register may consists of S.No, Date, Name of the Product, batch No, Mfg Date, Exp Date, Qty of samples withdrawn, done by (IPQA), checked by (QC), Qty. of sample Withdrawn, done by(QC),Checked by(QC) Qty Left and remarks. 10

11. Records  Samples destruction record consists of Date, Name of the sample, batch No, Mfg. Date, Expiry date, Qty, Destruction supervised by(QC) and Checked by (QA) and remarks.  Physical observation record consists of the Date, name of the samples, batch No, Mfg date, Expiry date, Observation, remarks. 11