 |
Buildings layout and internal construction/surface finishes |
|
Materials flow and personnel movement |
|
Product and materials storage and sampling |
|
Equipment |
|
HVAC Systems |
|
Water Systems |
Preparation of documentation, such as Standard Operating Procedures (SOPs), manufacturing and packaging records, Quality Control specifications and test methods and validation protocols
Assessment of GMP compliance to International Regulatory Standards, covering the manufacture of :
|
|
Nonsterile formulations, such as tablets, capsules, creams, ointments, external and internal liquids. |
|
Active Pharmaceutical Ingredients (API's) |
|
Intermediates |
| |
TOP |
| Training |
| |
|
As a technical consultant, Training should be regularly conducted by qualified individuals to the organizations and should cover (i.e. GMP and GLP), at a minimum, the particular operations that the employee performs and GMP as it relates to the employee's functions. |
| |
|
| Quality Management |
| |
|
 |
Reviews of Quality Control sampling and testing programs to maximize use of resources |
|
Analytical method validation |
|
Development of analytical equipment calibration programs |
|
Reviews and implementation of Good Laboratory Practice (GLP) |
| The preparation of laboratory documentation covering, for example: |
|
Standard Operating Procedures |
|
Specifications |
|
Test methods |
|
Sampling plans |
| |
TOP |
| Internal and External Audits |
|
Conducting mock GMP audits, prior to the customers and regulatory authority audits, to assess the level of GMP compliance |
|
Participation in GMP audits by regulatory agencies and post audit follow up activities, such as the preparation of a response to any issued audit report |
| |
|
| Validation and Qualification |
|
The preparation of: : |
|
Validation of Master Plans (VMPs) |
|
Process Validation Protocols and Reports including review of data |
|
Validation Protocols (covering DQ, IQ, OQ and PQ) |
|
Validation reports including reviews of data |
|
Analytical method validation protocols |
|
Analytical method validation reports including reviews of data |
| |
|
| Regulatory Agency Documentation |
|
The preparation of: : |
|
Drug Master Files for submission to the United States FDA and
the European Community, EDQM, MCC, TGA , Canadian Authorities and other semi regulated market |
|
Drug Product Dossiers for US , European Authorities and semi regulated market |
|
Responses to audit reports and follow up activities |
|
Site Master Files |
| |
TOP |
