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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

RECOVERY & REPROCESSINGMATERIAL

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.

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.

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.

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

THANK YOU