Scribd
Upload
277 views7 pages

GMP Training

The document discusses Good Manufacturing Practices (GMP), including what GMP is, why it is needed, an overview of GMP documentation, advantages of good GMP practices, and disadvantages of poor GMP practices. GMP aims to ensure products are consistently manufactured and controlled according to quality standards for their intended use. The basic requirements of GMP are that manufacturing processes are clearly defined and capable of producing quality products, facilities and equipment are adequate, records are made and retained, and defective products can be recalled.

Uploaded by

Md Saiful islam Bhuiyan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
277 views7 pages

GMP Training

The document discusses Good Manufacturing Practices (GMP), including what GMP is, why it is needed, an overview of GMP documentation, advantages of good GMP practices, and disadvantages of poor GMP practices. GMP aims to ensure products are consistently manufactured and controlled according to quality standards for their intended use. The basic requirements of GMP are that manufacturing processes are clearly defined and capable of producing quality products, facilities and equipment are adequate, records are made and retained, and defective products can be recalled.

Uploaded by

Md Saiful islam Bhuiyan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
You are on page 1/ 7

Training Content

• What is GMP ?
• Why do we need it ?
• GMP Documentation Overview
• Advantages of Good GMP practices
• Disadvantages of Poor GMP practices

GMP TRAINING 1
GENERAL PLANT
GMP- What does it mean ?

• Get Monty
Panesar?

Good Manufacturing
Practice

GMP TRAINING 2
GENERAL PLANT
GMP- What does it mean ?

 Good Manufacturing Practice is that part of


Quality Assurance which ensures that products
are consistently produced and controlled to the
quality standards appropriate to their intended
use and as required by the Marketing
Authorisation or product specification

 Good Manufacturing Practice is concerned with


both production and quality control

GMP TRAINING 3
GENERAL PLANT
The basic requirements of GMP are that:

 All manufacturing processes are clearly defined,


systematically reviewed in the light of experience and shown
to be capable of consistently manufacturing medicinal
products of the required quality and complying with their
specifications;
 Critical steps of manufacturing processes and significant
changes to the process are validated;
 All necessary facilities for GMP are provided including:
 Appropriately qualified and trained personnel
 Adequate premises and space
 Suitable equipment and services
 Correct materials, containers and labels
 Approved procedures and instructions
 Suitable storage and transport

GMP TRAINING 4
GENERAL PLANT
The basic requirements of GMP are that:

 Instructions and procedures are written in an instructional


form in clear and
 Unambiguous language, specifically applicable to the
facilities provided;
 Operators are trained to carry out procedures correctly;
 Records are made, manually and/or by recording
instruments, during manufacture which demonstrate that all
the steps required by the defined procedures and
instructions were in fact taken and that the quantity and
quality of the product was as expected. Any significant
deviations are fully recorded and investigated;
 Records of manufacture including distribution which enable
the complete history of a batch to be traced, are retained in a
comprehensible and accessible form

GMP TRAINING 5
GENERAL PLANT
The basic requirements of GMP are that:

The distribution (wholesaling) of the


products minimises any risk to their quality
A system is available to recall any batch of
product, from sale or supply;
Complaints about marketed products are
examined, the causes of quality defects
investigated and appropriate measures
taken in respect of the defective products
and to prevent reoccurrence.

GMP TRAINING 6
GENERAL PLANT
GMP TRAINING 7
GENERAL PLANT

You might also like

pFad - Phonifier reborn

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


Alternative Proxies:

Alternative Proxy

pFad Proxy

pFad v3 Proxy

pFad v4 Proxy