PHARMACEUTICAL QUALITY ASSURANCE

PT. 611
 UNIT IV
• Complaints: Complaints and evaluation of
complaints, Handling of return good,recalling
and waste disposal.
• Document maintenance in pharmaceutical
industry: Batch Formula Record, Master
Formula Record, SOP, Quality audit, Quality
Review and Quality documentation, Reports
and documents, distribution records.
1. What is complaint?

2. Classification of complaints

3. Responsibility of complaints

4. Complaint Handling procedure

 Complaint Handling Procedure
1. Receiving complaint
2. Technical investigation
(Documentation based and Laboratory Analysis
phase)
(Confirmed complained, non-confirmed
complained, counterfeit/Tamper suspicion)
3. Corrective action and feedback to the
customer
4. Monthly report and trend analysis
 Confirmed complained
(OOS : out of specification
Single unexplained failing product)

non-confirmed complained
(Compliance with specification, misuse/mishandling,
Single explained failing product)

Counterfeit/Tamper suspicion
(30 days, 1 year)
CAPA Team (QA, QC, Regulatory affairs,
Production management, Free replacement
product, response letter, Corrective
measures to provide orientation to the
customer)
 Monthly reports and trend analysis
(How many? Confirmed? Unconfirmed?
Nature?
Sharing of report
Pareto analysis for identification
& implementation of corrective action,
Sharing of report with all department,
Monthly report to the annual product review
elaboration)
What is Recall?
Most effective way to protect the public from a
defective or potentially harmful product.

Primary reason for product recall

(Reason: FDA, Manufacturer, Accidental damage

Types of recall:
Consumer product safety act, section 15 (b),
ICCC: Independent Consumer and Competition
Commission
Primary reason for product recall

1. FDA: substandard quality

2. Manufacturer: substandard quality;
stability problem; complained
3. Accidental damage: during transportation;
Packaging problem
 Handling of return good
: check COA and other documents with the
returned consigned

: condition of the packaging, carton and container

: Labelling details
Pharmaceutical Waste Treatment and Disposal

1. Incineration
2. Autoclaving
3. Microwaving
4. Deep burial
5. Surface land filling
6. Encapsulation
7. Sewer
 Master Formula Record
1. Uniformity
2. Number assignment (MFR/1980/001.R12020)
3. Name, strength, dosage form
4. Name, Weight
5. Complete list, double identification
6. Same weight system
7. A statement including
8. Equipment
9. Step-wise manufacturing process
10.Space for signature
11.Description of Container, closure, and packaging
12.Theoretical and practical yields
 Batch Formula Record
1. Manufacturing history
2. It should be…
3. Processing operations and control
4. Single batch of production
5. Assignment of number
6. Individual major equipments
7. Specific identification and quantities
8. Yield
9. Signed authorization
10.Any sampling
11.Identification of the person
12.2 year or 5 years