This document discusses vendor qualification and product returns and recalls in the pharmaceutical industry. It provides definitions and guidelines for recall classification, initiation, and responsibilities of recalling firms. It also discusses vendor qualification categories and criteria for selection. The key points are that recall means removing violating products from the market, while return means sending unused products back. Firms must qualify vendors on various criteria like quality, delivery, and facilities to ensure consistent product quality.

1. M. Pharm Sem-I Presentations
Return And Recall,Vendor Qualification
SUBMITTED TO
SAVITRIBAI PHULE, PUNE UNIVERSITY , PUNE
FOR
PARTIAL FULFILMENT OF REQUIREMENTS FOR THE AWARD OF
MASTER OF PHARMACY
IN THE SUBJECT
Pharmaceutical Quality Assurance
IN THE FACULTY OF SCIENCE AND TECHNOLOGY
Bhujbal Knowledge City,
MET’s Institute of Pharmacy,
Adgaon, Nashik, 422003.
Maharashtra, India
Academic Year 2021-22 1
Presented By-
Hammad md Athar
Guided By
Dr S.PAhirrao

2. RECALL
• Recall means a firm’s removal or correction of a
marketed product(s) that the Food and Drug
Administration considers to be in violation of the
laws it administers and against which the agency
would initiate legal action.
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3. RECALL INITIATION
• Recall may initiated in three ways:
1. Firm initiated Recalls: A manufacturer or distributor may
voluntarily initiate a recall at any time.
2. FDA requested Recalls: Under certain urgent situations, FDA
may request that a manufacturer or distributor recall a product.
3. FDA Ordered Recalls: Under certain authorities, FDA may
mandate a recall. It includes: – Mandatory Device recalls –
Mandatory of biological products – Mandatory recall of human
tissue intended for transplantation – Infant formula
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4. RECALL CLASSIFICATION
• Numerical designation (i.e., I, II, or III) is assigned by
FDA to a particular product recall to indicate the
relative degree of health hazard presented by the
product being recalled.

5. RECALL CLASSIFICATION
• Class I
• Class I is a situation in which there is a reasonable
probability that the use of, or exposure to, a violative
product will cause serious adverse health
consequences or death. Examples of Class I Recalls
• Pathogens in ready-to-eat food: Salmonella
• High levels of sulfites
• High levels of heavy metals
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6. CLASS II AND CLASS III RECALLS
• Class II
• Is a situation in which use of, or exposure to, a violative product may cause
temporary or medically reversible adverse health consequences or where
the probability of serious adverse health consequences is remote.
• Examples of Class II Recalls
• Foreign objects that pose a physical hazard
• CLASS III
• RECALLS Class III is a situation in which use of, or exposure to, a violative
product is not likely to cause adverse health consequences.
• Example of Class III Recalls An example might be bottles of aspirin that
contains 90 tablets instead of the 100 stated on the label

7. RESPONSIBILTIESOF RECALLING FIRM
• Preparing for a recall
• Review available recall guidance
• Develop a recall plan
• Maintain manufacturing and distribution records in a manner to facilitate a timely and
effective recall
• Identify finished products with a lot number
• Determining the scope of the recall.
• When did the problem start/end?
• Can additional lots/products be affected other than the lot/product analyzed and
found adulterated? •How many sizes/labels for the product?
• Is the product coded with a lot number?
• Shelf life of product

8. RETURN
• Difference between return and recall is that return is
to come or go back (to a place or person)
while recall is to withdraw
• The “drug return” process is also known as reverse
distribution. Often, this process is coordinated by a
reverse distribution company, e.g., Pharma Logistics.
This company takes your pharmacy’s unsalable,
expired drug products, sends them back to
manufacturers and/or wholesalers for credit, or
disposes of them.

9. CASE STUDY
• In the fall of 1982, seven people in the Chicago area
died after ingesting Extra- Strength Tylenol laced with
potassium cyanide. Sparked a citywide panic; for
days, police cruised the streets, blaring warnings that
residents should discard the product. Johnson &
Johnson spent millions of dollars recalling Tylenol
from stores nationwide.

10. VENDOR Qualification
DEFINATION:
is a supplier-customer partnership and can only be
successful with the full involvement and agreement
of both partners
OR
• It is the system that assure that a supplier’s
product is produced under controlled condition,
resulting in consistent quality Conformance.

11. CATEGORY – 1
• Generally regarded as EXPERTS.
• Short lived’ in development cycle.
• Contracted to perform limited scope of work.
• Minimal monitoring

12. CATEGORY 2
• Well known suppliers of standard containers
,closures ,raw materials and excipients .
• Certified to an International Standards
Organization (ISO)- 9000 quality management
system.
• Enhanced monitoring is suggested.

13. CATEGORY 3 AND 4
• Category 3 vendors may be category 2
vendors who are experiencing quality issues
with current incoming inventory or have
shown a trend of non-conformance over the
last 12 months.
• Can be contract laboratory operations that
provide routine analysis, sometimes in large
quantities.

14. WHY TO QUALIFY VENDORS ?
• Used to determine if the vendor is appropriate for
the scope of work.
• Critical attributes of a partner relationship are
Supplier or customer commitment to a long term
relationship.
• Information sharing.

15. selection criteria
1. Quality
2. Delivery
3. Performance history
4. Warranties and claim polices
5. Production facilities and capacity
6. Financial position
7.Price 8. Technical capability
9. Procedural compliance
10.Communication system
11.Reputation and position in industry 12.Desire for business

16. REFERENCE
• Sidney H. Willing, “Good Manufacturing Practices for
pharmaceuticals”, Drugs and Pharm. Sci. Series, Vol.
109Marcel Dekker Inc
• http://www.fda.gov/Safety/Recalls/default.htm