1. GMP
o DISTRIBUTION
o DISTRIBUTION RECORD
o HANDLING OF RETURNED GOODS
o RECOVERY & REPROCESSING
MATERIAL
GUIDED BY: PRESENTED BY:
Mr. PRATIK NAYAK DESAI YAD M.
M.PHARM (Q.A)
SEM-1

2. Distribution procedures
 Written procedures shall be established and followed,
describing the distribution of drug products. They shall
include:
 A procedure whereby the oldest approved stock of a drug
product is distributed first.
 A system by which the distribution of each lot of drug
product can be readily determined to facilitate its recall if
necessary.

3.  Distribution record must be constructed and procedures
established to facilitate recall of defective product.
 Manufacturer must maintain record of all distribution
transactions involving in process or finished goods.
 All record should be indexed by either manufacturing
batch-lot number of the packaging control number as a
means of accountability until the shipment passes from
the direct control of the manufacturer.

4.  The distribution process also include other
considerations, it must be arranged so that a first in /first
out movement of product occurs.
 These requirement is consistent with the intent of the
stability and expiration dating policy.

5.  APIs should only be released for distribution to third
parties after they have been released by the quality unit.
 API's may be transferred under quarantine to another
unit under the company’s control when authorized by
the quality unit and providing appropriate controls and
documentation are in place.
 APIs should be transported in a manner that does not
adversely affect their quality.
 Special transport or storage conditions for an API should
be stated on the label.

6.  The API manufacturer should ensure that the contractor
for transportation of the API knows and follows the
appropriate transport and storage conditions.
 A system should be in place by which the distribution of
each batch of intermediate and/or API can be readily
determined to permit its recall.

7. DESTRIBUTION RECORD
 Distribution records shall contain the name and strength of
the product and description of the dosage form, name and
address of the consignee, date and quantity shipped, and lot
or control number of the drug product.
 For compressed medical gas products, distribution records
are not required to contain lot or control numbers.
 The primary purpose of this section is to ensure that
adequate data are available to access trade customers
should a recall be initiated.

8.  Distribution records include a wide range of documentation
such as invoices, bills of lading customers’ receipts, and
internal warehouse storage and inventory records.
 The information required need not be on every document.
Also customer codes and product codes may be used as
alternates to customer names and addresses and product
names.
 Records for distribution shall be maintained in a manner
such that finished batch of a drug can be traced to the
retain level to facilitate prompt and complete recall of the
batch, if and when necessary.

9. Handling of Returns Goods
 Finished product may be returned to the company or its
Authorized nominees for one or the other reasons.
 Such returned goods may either be destroyed or
reconditioned and made it for use. Clear guidelines in
this regard must therefore exist and be followed.
 Head of quality control shall be primarily responsible to
formulate detailed procedures for dealing with the
handing of return goods and implement this procedure.

10.  For each return, documentation should include:
Name and address of the consignee , Intermediate or
API, batch number, and quantity returned, Reason for
return, Use or disposal of the returned intermediate or
API.

11.  Returned drug products shall be identified as such and held.
 If the conditions under which returned drug products have
been held, stored, or shipped before or during their return,
or if the condition of the drug product, its container, carton,
or labeling, as a result of storage or shipping, casts doubts
on the safety, identity, strength, quality or purity of the drug
product, the returned drug product shall be destroyed unless
examination, testing or other investigations prove the drug
product meets appropriate standards of safety, identity,
strength, quality, or purity.

12.  Products returned from the market should be destroyed
unless it is certain that their quality is satisfactory; in such
cases they may be considered for resale or relabeling, or
alternative action taken only after they have been critically
assessed by the quality control function in accordance with a
written procedure.
 A drug product may be reprocessed provided the subsequent
drug product meets appropriate standards, specifications, and
characteristics.

13. RECOVERY & REPROCESSING
MATERIAL
 Introducing an intermediate or API, including one that does not
conform to standards or specifications , back into the process
and reprocessing by repeating a crystallization step or other
appropriate chemical or physical manipulation steps (e.g.,
distillation, filtration, chromatography, milling) that are part of
the established manufacturing process is generally considered
acceptable.
 If such reprocessing is used for a majority of batches, such
reprocessing should be included as part of the standard
manufacturing process.

14.  Such reprocessing should be preceded by careful evaluation
to ensure that the quality of the intermediate or API is not
adversely affected due to the potential formation of by
products and over-reacted materials.
 Recovery of reactants, intermediates, or the API is considered
acceptable, provided that approved procedures exist for the
recovery and the recovered materials meet specifications
suitable for their intended use.

15.  Solvents can be recovered and reused in the same
processes or in different processes, provided that the
recovery procedures are controlled and monitored to
ensure that solvents meet appropriate standards before
reuse or commingling with other approved materials.
 Fresh and recovered solvents and reagents can be combined if
adequate testing has shown their suitability for a
manufacturing processes in which they may be used.
 The use of recovered solvents, mother liquors, and other
recovered materials should be adequately documented.

16. REFERENCES
 Sidney H. Willing, “Good Manufacturing Practice for
Pharmaceuticals” Marcel Dekker, Page no 132
 www.fda.gov/downloads/.../Guidance/ucm129098.pdf
 D .H. SHAH “QA MANUAL” , First edition, Business
horizons publication, page no: 152,156, 180, 181

17. THANK YOU