Compliance Projects provide the development and improvement of
management systems and good manufacturing practices (GMP) e.g.
cleanroom design, hygiene controls, through the implementation and
re-alignment to international business standards and best practice
in the areas of Medicine and Medical device regulation, Quality
Management, Environmental Management, Health & Safety Management,
Food safety management and Corporate Governance.
Our target is the pharmaceutical, medical device, toiletries and
food industries (FCMG – fast moving consumer goods) focussing on
Good Manufacturing Practice (cGMP) which requires effects and
practices that; |
 |
 |
Minimize
any risk of errors, |
|
|
Avoid
cross-contamination and contamination, |
|
|
Avoid
mix-up and Eliminate any adverse effect on quality |
|
Our Scope of
business includes;
 |
Conceptual design & Time plan & Estimation of costs |
|
|
Project
plan |
|
|
Detailed
engineering design & scoping |
|
|
Preparation of tender documentation |
|
|
Client
assistance in tender adjudication & award |
|
|
Preparation of contractual documents for projects |
|
|
Project
management during works |
|
|
Engineering QC & QA |
|
|
Collation of records and compliance certificates |
|
|
Qualification of facility (clean-rooms) & utilities
(compressed air, steam) |
|
|
Equipment qualification & validation |
|
|
Water
treatment, HVAC qualification & validation |
|
|
Standard
operating procedures & instructions |
|
|
Laboratory (wet, instrumentation and
microbiological) design and qualification |
|
|
Training
(cGMP and Technical) |
|
 |
Projects:
Champion Healthcare – Ragen Reddy, 031 5700550,
info@kznoils.co.za
PacCon Pharmaceuticals – Prakash Bissoon, 0319140174,
prakashb@pac-con.co.za
Allied Drug Company – Graham Taylor, 0312054271,
g.taylor@alphafactory.co.za
Mondi Packaging Pinetown- Neil Waterer- (031)710-5800
Neil.Waterer@mondigroup.co.za
BSN medical- Nils von Klemperer – 0317108111,
Nils.VonKlemperer@bsnmedical.co.za |
Joint Venture
with combined experience from Rickitt Benckiser/ Enaleni and
Smith & Nephew / BSNmedical respectively:
Simone Rudolph-Shortt (dip
Pharm)
Dip Production Management
Rudolph-Shortt Consultancy cc
P.O.Box 1577, WANDSBECK, 3631
Cell: 082 8715740
Phone : 031 2623180
Fax : 088 0312623180
e-mail:
simone@complianceprojects.co.za |
Pedro Thavar (Mech
Eng.)
Member ISPE (International Society
of Pharmaceutical Engineers)
Dip.Project Management
PVT Projects
15 Ganesh Road,Clairwood,4050
Phone: 031465 5984 Fax: 0866 942353
Mobile: 0843013221
E-mail:
pedro@complianceprojects.co.za |
|
