GMP (Good Manufacturing Practices) are a system for ensuring that products are consistently produced and controlled according to quality standards. GMP aims to minimize risks in pharmaceutical production that cannot be eliminated through testing of the final product. Key aspects of GMP include properly designing and constructing facilities and equipment, documenting work, conducting validation, monitoring processes, controlling components and products, carrying out audits, and generating necessary documents like SOPs, specifications, records and reports. GMP guidelines provided by regulatory bodies help ensure human and veterinary medicines are safe, effective and meet quality standards.

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