RESERVE SAMPLES

SRIKANTH NAGABIRU, M.Sc, C.D.A.C

Author Working for pharmaceutical Company
and living in Hyderabad, Telangana, INDIA
http://stabilitystudies.blogspot.in Contact No: +91-7680 925 295
Weekly Newsletter
Regulatory Requirements Reference sample:
Starting material or finished product or
1. US FDA- 21 CFR 211.170 Reserve packing material which can be stored for
samples the future analysis if the need arises
2. EudraLex, Volume-4, Annexe 19: during the shelf life of the Batch
reference or retention samples concerned.
3. Swiss medicines Inspectorate(Article
7 Paragraph 3, c and d MPLO Retention sample:
(Medicinal Products Licensing Sample collected from the batch. These are
Ordinance, SR 812.212.1) : useful for referring the packing style, batch
retention samples number, Mfg date, Exp date, Patient leaflet
4. PIC/S Good Manufacturing Practice or any other relevant information for the
for medicinal Products Volume-II batch concerned during shelf life.
section 11.7 reserve or retention
samples. Sample Size and analysis:
5. WHO-Quality Assurance of
Pharmaceuticals - A Compendium of Samples shall be collected for Starting
Guidelines and Related Materials - material, Finished Products and packing
Volume 1(1997), Section 2.7 materials for each and every batch of the
Retention samples. manufacturing.
6. ICH, Q7A For active Pharmaceutical
Ingredients 11.7 reserve or Samples shall be Collected in such a way
retention samples that the quantity minimum required for
two times full analysis as per compendial
analysis or In-house product specification.
Definitions:
Each and every analysis shall be carried
These are also called retention samples or out on unopened pack.This statement
control samples. generally refers to the liquid oral products
or Powders.
Types of Reserve samples
Schedule M (Regulatory guidance for
Reference sample and retention sample INDIA) quoted as "All the tests shall be
performed except Sterility or bacterial
Endotoxins".
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.
Physical observation of the samples:
Visually inspect the samples for every six
months. Record the observations in the
register.
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 whichever is longer (21 CFR
211.170 Reserve samples).
Sample Deterioration:
Any deterioration observed during
inspection or analysis the batch shall be
investigated ( 21 CFR 211.192(Production
record review).
Destruction:
Destroy the samples after retention period.
Destruction shall comply as per the
regulatory requirements of their country(
Solid waste disposal or liquid waste
disposal etc..)
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.
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 sample, batch No, Mfg
date, Expiry date, Observation, remarks.