|
|
|
Pharmaceutical Manufacturing and Packing Sourcer
|
The term 'cleaning validation' has been known to make grown men cry, or at least shake with fear! It is a much misunderstood process yet can be relatively straightforward if tackled correctly and methodically. Cleaning validation can be defined as 'documented evidence that has a high level of assurance, where a cleaning process will consistently produce equipment and products meeting pre-determined quality specifications.' There are many approaches to establishing a rugged, documented, validated cleaning programme. Here we will discuss just one option of approaching cleaning validation in a systematic way, to achieve the final cleaning goal.
Step 1
In this initial step, there are four tasks to accomplish before being able to move to Step 2.
1. Identify and keep a record of all manufacturing and filling equipment, which is dedicated to one product or used for multiple products. Equipment used for multiple products may be considered (provided it is qualified) for product grouping as an alternative to individually validating all the products processed with the same equipment. Similarly constructed equipment is defined as having a different size, but built with the same material of construction when compared to the equipment train in the specific group.
|
Read full article from PDF >>
|
|
 |
|
| Rate this article |
You must be a member of the site to make a vote. |
|
Average rating: |
0 |
| | | | | |
|
|
 |
News and Press Releases |
 |
Destiny Pharma appoints MedPharm to develop new XF-platform drug formulations
Destiny Pharma, a clinical stage biotechnology company focused on the development of novel antimicrobial drugs, is pleased to announce that it has appointed MedPharm as its expert partner to develop new topical formulations of the Company’s novel XF-platform compounds. These new treatments for dermal and ocular infections are part of its second clinical programme to address the global problem of anti-microbial resistance (AMR). MedPharm is a world leading contract provider of topical and transdermal product design and formulation development services using sophisticated in vitro models to de-risk development programmes.
More info >> |
|
 |
White Papers |
 |
|
Novo Nordisk Pharmatech A/S signs distribution agreement with DKSH for twelve countries in Asia Pacific.
Novo Nordisk Pharmatech A/S
Novo Nordisk Pharmatech A/S and DKSH, have partnered to provide high-quality cGMP quaternary ammonium compounds in twelve countries across Asia Pacific.
More info >> |
|
 |
Industry Events |
 |
SAPHEX 2019
23-24 October 2019, GALLAGHER CONVENTION CENTRE, 10 RICHARDS DRIVE, HALFWAY HOUSE, MIDRAND, 1685, SOUTH AFRICA
SAPHEX 2019 will be held on the 23rd-24th October at the Gallagher Convention
Centre, Johannesburg, South Africa.
More info >> |
|
|
