The document outlines post-operational activities in pharmaceutical manufacturing, focusing on distribution, recalls, returns, and handling complaints. It emphasizes the importance of maintaining records for product distribution and establishing protocols for managing recalls and returns due to quality issues. Regulatory guidelines are provided for ensuring compliance and safeguarding product quality throughout these processes.

1. POST-OPERATIONAL ACTIVITIES
PRESENTED BY:
SUNISH.S.JAGTAP
FIRST YEAR M.PHARMACY SEM 1(QAT)
BHARTI VIDYAPEETH DEEMED UNIVERSITY,
POONA COLLGE OF PHARMACY,ERANDAWANE ,PUNE
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2. Introduction:
 Pharmaceutical manufacturing and distribution is a ‘cyclic’ process.
Developing
Pharmaceutical
manufacturing
and distribution
manufacturing
Distribution to
customer to
customer
Feedback to
manufacturer
Good/bad
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3. Hence regulatory guidelines are availaible on following post operation activities……
Distribution
Recalled
products
Returned
products
Complaints
and adverse
effects
Drug
product
salvaging
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4. 1)Distribution
 The manufactured finished drug products are distributed by the manufacturers for sale
or samples to the doctors .when the products are distributed ,a detailed record of its
distribution is to be maintened ,at least upto the wholesales
 This record may not be availaible at the factory but may be traceable at different
stages- factory warehouse
-c and f agents
Following are guidelines in regulatory literature:
1) Finished products should be held in quarantine until their final release ,after which these
should be stored as unable stock under contitions established by manufacturer
2) Records of evauation and its fitness for distribution should be availaible with the
manufacturer
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5. 3)The distribution records shall contain the following things,namely:
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a)Name and strength of the product
b)Name and address of the consignee
c)Date and quantity shipped .
d)lot/ batch/ control number of drug product
RECALLED PRODUCTS:
1)The distributed product may be recalled by the manufacturer for various reasons,some of the
reasons may be as follows :
a)F.D.A authorities may order a recall for substandard quality of the product
Or for any other justified reason

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2)Manufacturer himself may find problems with the product ,such as substandard
Quality ,which has been detected after release of the product ,problems related ,to stability
Of the product or based on the market complaint received from a customer or physician.
3)Accidental damage of the consignment may also happen during transportation.
In such cases the product quality may not be questionable, but packages may get damaged
and cannot be sold or distributed as such in the market ,and hence required to be cancelled.
E.g baxter initiated voluntary recall of one lot of highly concentrated potassium chloride
injection in the U.S due to mislabelled overpouch .
REGULATORY GUIDELINES PROVIDE GUIDANCE ON HANDLING OF PRODUCT RECALLS FOLLOWING
POINTS SHOULD BE CONSIDERED (21CFR 7,sub A and C RECALLS;21 CFR 107,SUB E-mandatory
recall of infant formula;21CFR 1270-human tissue;PHS act -42 U.S.C262-mandatory recall of
biological products;21CFR806 medical device corrections and removals;
FD&C,518(e) –mandatory device recalls
a)A detailed SOP should be available and records of recall should be maintained by the
manufacturer.

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b) A person should be designated as responsible for execution and co-ordination(he may be
a senior person from QA section) and should be supported with sufficient staff to handle all
aspects of recall with the appropriate degree of urgency .
This person should be normally be independent of the sales and marketing organisation.if this
person is not authorised person ,then the authorised person should be made aware of any
recall operation ..
c)Recall procedure should be capable of being indicated promptly and at any time.
d) All competent authorities of the countries to which the product might have been
distributed should be informed promptly if products are intended to be recalled because
these are ,or suspected of,being defective.
e)The distribution records should be readily availaible to the person responsible for recalls,and
should contain ,sufficient information on wholesellers and directly supplied
customers(address,phone,fax number during outside working hours ,batche and quantity
delivered),including those for exported products and medicinal samples.

8. f) Recalled products should be identified and stored separately in a secured area while awaiting
decision on its fate.
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g)The program of the recall process should be recorded and final report issued including a
reconciliation between the delivered and recovered quantities of the product.
h)The effectiveness of the recall procedure should be evaluated from time to time by a dummy recall.
i)A detailed check list may be designed by the manufacturer to recall a product.
e.G aurobindo pharma USA ,issues voluntary recall of northstar ,label GABAPENTIN
capsules,usp 300 mg due to complaints of empty capsules
Returned products
Distributed finished products can be returned for various reasons. These can be for ,substandard quality
,damaged of packaging,stability related issues; or any other such reasons.
Regulatory guidelines are available in how handle such issues.
a)Products returned from the market shall be identified ,and stored securely and should be
destroyed unless it is certain that its quality is satisfactory;these may be considered for resale
,relabeling or bulking with subsequent batch only after these have been critically assessed by
the quality control department in accordance with a written procedure.

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b)Where even slightest doubt arises over the quality of the product, it should not be considered for
reissue or reuse ,although basic chemical reprocessing to recover the API may be possible
c) A finished pharmaceutical may be reprocessed provided the subsequent product meets Appropriate
standards ,specifications ,and characterstics.
d)If the reason for a drug product being returned implicates associated batches,an appropriate
investigation shall be conducted
e)Records of returned drug product shall be maintened and shall include the following :
1)The name and label potency of the drug product dosage form.
2)lot/ control /batch number of the product.
3)Reason for return.
4)Quantity returned date of dipostion
5)Ultimate disposition of the return drug
DOCUMENTS REQUIRED: i)SOP on handling returned drug products
ii)Records of returned drug products including action taken on it and associated batches if any.

10. Returned products
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Distributed finished products can be returned for following reasons:
1)Substandard quality
2)Damaged of packaging ,stability related issues, or any other such reasons.
REGULATORY GUIDELINES :
a)Products returned from the market shall be identified ,and stored securely and may be
considered for resale ,relabeling ,or bulking with a subsequent batch only after for resale
,relabeling ,or bulking with subsequent batch only after these have been critically assessed by
quality control department in accordance with a written procedure.
b)Where even slightest doubt arises over the quality of the product,it should not be
considered suitable for reissue ,or reuse ,although basic chemical reprocessing to recover
the API may be possible.
c)If the reason for a drug product being returned implicates associated batches ,an
appropriate investigation shall be conducted(ref USFDA guideline 211.192)

11. d)Records –
Name and label potecy of drug product dosage form
Lot /control /batch number of the drug product
Reason for return
Quantity returned
COMPLAINTS AND ADVERSE EFFECTS
a)Adverse event or experience
b)Adverse drug reactions
c)Unexpected adverse drug reaction
Regulatory literature:
1)Sop is must
2)QM person should be designated for handling the complaints.
3)If product defect found then other batches should also checked
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12. DRUG PRODUCT SALVAGING
TO SAVE THE DRUG FROM SALVAGING MEANS PROTECTION OF ITS QUALITY
SHOULD NOT GET HARMED
DOCUMENTS :
1)SOP ON QUARANTINE OF FINISHED PRODUCT BEFORE RELEASE BT Q.C
2)SOP ON STORAGE MATERIALS
3)SOP ON FINISHED PRODUCTS
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13. THANKYOU
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