|
|
|
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 |
 |
3P Biopharmaceuticals receives FDA approval
[Pamplona, September 16th, 2019] 3P Biopharmaceuticals (3P), a leading Contract Development and Manufacturing Organisation (CDMO) specialized in process development and GMP manufacturing of biologics, receives FDA approval after completing the Pre-Approval Inspection (PAI) conducted at the 3P drug substance manufacturing facility.
More info >> |
|
 |
White Papers |
 |
|
Mouse Models for Evaluation of Vaccines and Therapeutics Against Staphylococcal Infections
IBT Bioservices
Introduction
Staphylococcus aureus (SA) is a ubiquitous, formidable
Gram-positive pathogen associated with skin and soft tissue, as well as
lifethreatening systemic infections. SA is a leading cause of hospital- and
community-associated infections worldwide, affecting humans and animals. The
wide range of pathologies reflects the diverse abilities of this microbe to
escape the innate and adaptive immune response using virulence factors. Since
its first emergence in the 1960s methicillin-resistant SA (MRSA) has become
endemic in hospitals and healthcare settings worldwide. In the 1990s, community
associated MRSA strains (CA-MRSA) emerged, and are spreading worldwide posing a
major global challenge.
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 >> |
|
|
