1POST-OPERATIONAL ACTIVITIESPRESENTED 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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2Introduction: Pharmaceutical manufacturing and distribution is a ‘cyclic’ process.

Pharmaceutical manufacturing and distribution

Developing

manufacturing

Distribution to customer to

customer

Feedback to manufacturer

Good/bad

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3Hence 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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41)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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53)The distribution records shall contain the following things,namely:

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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62)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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7b) 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. 15/04/202

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8f) Recalled products should be identified and stored separately in a secured area while awaiting decision on its fate.

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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9b)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.

10Returned products

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) 15/04/202

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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 EFFECTSa)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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12DRUG 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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THANKYOU