QC and QA play important roles in ensuring the safety, efficacy, and quality of pharmaceutical products. QC evaluates quality throughout the manufacturing process, testing all raw materials, drug products, and packaging components. This includes identity, purity, and dissolution testing using techniques like HPLC, spectroscopy, and titration. QA is responsible for ensuring compliance with regulations from organizations like the FDA and adherence to pharmacopeial standards. Proper testing and retention of samples helps guarantee drug quality from production to expiration.

1. Role of Q.C & Q.A in Pharmaceutical IndustryRole of Q.C & Q.A in Pharmaceutical Industry
PresentedPresented ByBy
Rezowanul HaqueRezowanul Haque
PharmacistPharmacist
Daffodil Internation al UniversityDaffodil Internation al University
BangladeshBangladesh

2. QC Roles
Evaluation of quality throughout process:
Raw materials and API
Drug Product
Packaging components
Reassay
Retains

3. QC Responsibilities
Efficacy
Safety
Quality
Compliance
 FDA, MHRA, ICH
 USP, BP, EP, JP

4. Raw Materials
All Raw Materials are tested on site before use
Incoming identity
Full release testing
Includes Excipients, Capsules, API
Various techniques
Raman and IR Spectroscopy
Assay (HPLC and Titration)
Physical Tests

5. Packaging Components
All packaging components tested if in contact
with drug product
Bottles
Blister pack components
Cotton wool, Desiccants
Range of techniques
Appearance
Spectroscopy
Loss on Drying

6. Finished Product (Release)
Release into Clinic
Mainly 2 techniques
HPLC
Dissolution
Several tests
Assay
Content Uniformity
Dissolution

7. Finished Product (Reassay)
Scheduled reassessment of released drugs
Ensures continued efficacy
Same techniques as Release
HPLC, Dissolution
Reduced testing for reassay
Reassay schedule drug dependant
Comparators –manufacturers expiry
In house drugs –decided by formulator

8. Retains
 Sample of everything tested retained
 Enough for full testing in duplicate
 At label conditions
 Retain time determined by regulatory
guidelines
 Raw materials 12 Years
 Finished products 10 Years
 All unsealed finished products inspected
annually

9. Cleaning Verification
All manufacturing equipment cleaned
Subject Exposure Limit (SEL) set
SEL converted to a Residue Limit (RL)
Equipment swabbed
Tested using HPLC

Std concentration made to RL

Swab concentration must be lower than std
All surfaces must be validated

10. Future
Process Analytical Technology
Paperless laboratory
Explore new uses of analytical techniques
NIR
IMS

11. Quality Assurance

24. Thanks to all