overview on GMP

1. GMP (Good
manufacturing practices)
Presented By:
NAME : DHUMAL KULDIP
FINAL YEAR B.PHARM

2. CONTENT
 GMP DEFINITION
 GMP PRACTICES
 RISK
 IMPORTANCE
 PRINCIPLE
 QC &QA
 GMP GUIDELINCE
 DOCUMENT

3. What is GMP
GMP is a part of Quality assurance which
ensure that the product are manufactured &
controlled to Quality std appropriate to
their intended use.

4. GMP PRACTICES
GMP Is that quality cannot be tested into batch
of product but must be built into batch of
product during all stages of mfg process.
It is designed to minimize risk in any
pharmaceutical production that can not be
eliminated through testing final product.

5. RISK
- Unexpected contamination of product
causing damage to health or even death.
- Incorrect label on containers which could
mean that patient receive wrong medicine.
- Insufficient or active ingredient, resulting
ineffective treatment or adverse effect.

6. IMPORTANT
- A poor quality medicine may contain toxic
substances that have been unintentionally
added.
- A medicine that contain little or none of the
claimed ingredient will not have the
intended therapeutic effect

7. PRINCIPLE
- Design and construct the facilities and
equipment properly
- Document work
- Validity work
- Monitor facility and equipment
- Control components & product related
process
- conduct plan & periodic audict

8. QA
- All those planned or systematic action
necessary to provide adequate confidence
that product will satisfy the requirement for
quality.
- Is a company based.

9. QC
- Operational laboratory tech. & activities
used to fulfill the requirement of quality.
- QC is lab based.

10. GMPGUIDELINES
• GMP as per schedule “M”
• GMP as per WHO
• GMP as per MCA now known as MHRA
• GMP as per TGA
• GMP as per US FDA
• GMP as per ICH guidelines

11. DOCUMENT
 Policies
 SOP ( Standard operating procedure)
 Specification
 MFR ( Master formula record)
 BMR ( Batch manufacturing record)
 Manuals
 MP ( Master plan)
 Validation protocols
 Form and formats
 Records

12. THE END