COURSE OBJECTIVES

To provide persons involved in the manufacture of complementary medicines with the
practical aspects and knowledge to be able to ensure that their company complies with the
current requirements for Good Manufacturing Practice.

To fulfil the MCC requirement that only staff trained in GMP may manufacture, distribute or
dispense medicine.
PQ13:
GMP II: Good
Manufacturing
Practice for
Orthodox and
Complementary
Medicines
Other Courses for
Production and Quality
Management Personnel:
Total Quality Management,
Good Manufacturing
Practices and Process
Validation
GMP I – Introduction to
Good Manufacturing
Practice
COURSE OUTCOMES
At the end of the course, participants will:

Demonstrate an understanding of the principles and meaning of current Good
Manufacturing Practice and its role in manufacturing Quality Medicines

Demonstrate an understanding of local and internationally recognised cGMP guidelines.

Appreciate the importance of Standard Operating Procedures and their absolute necessity
for the effective application of cGMP throughout their manufacturing facility.

Implement cGMP through full and ongoing application of knowledge gained from the PIC/S
guidelines and their specific requirements objectively and comprehensively into their own
Quality Assurance Systems and Standard Operating Procedures.
LEARNER PROFILE AND ENTRANCE REQUIREMENTS
Area personnel at the manufacturing site, packaging personnel, cleaning personnel, laboratory
personnel, quality assurance personnel and regulatory personnel. No prior knowledge of GMP is
required.
COURSE CONTENT

Orthodox versus complementary medicines

Contamination of medicines

Basic principles of GMP

Implementing GMP

Measuring/Assessing cGMP

Workshops on: Management functions
Labelling

Obstacles to effective GMP

Legislation and cGMP

International guidelines – WHO vs PIC/s

Workshop on:
PIC/s guidelines

Standard Operating Procedures

Application of cGMP principles according to PIC/s guidelines

Workshop on:
PIC/s guidelines

Effective GMP

Assessment:
Health Science Academy Learner Guide Assessment
PRESENTATION OF COURSE
Material is presented at an attendance workshop in small groups in Ferndale, Randburg, or as an
in-house course.
DURATION OF COURSE:
2 days. See our Pharmaceutical Industry Training Calendar for dates and fees.
COURSE MATERIAL
All lecture material is presented in a comprehensive course file.
ACCREDITATION
Health Science Academy (Pty) Ltd is accredited by the South African Pharmacy Council.
CERTIFICATION
Successful candidates will receive a certificate of competence.
BOOKING PROCEDURE
Contact Health Science Academy at:
Tel: (012) 816 9000
Fax: 086 298 0260
E-mail: hsaenquiries@healthscience.co.za, www.hsa.co.za
Health Science Academy reserves the right to make changes without prior notification
533567934
Struland Office Park, 173 Mary Road, The Willows, 0184
 2955, Randburg, 2125 South Africa
Tel: (012) 816 9000
Fax: 086 298 0260
e.mail: hsaenquiries@healthscience.co.za
www.hsa.co.za
Pharmaceutical Industry, Hospital and Community Pharmacy
Training Course Application Form
Applicant’s details
Surname
Name
Title (Mr/Mrs/Ms/Dr)
Race
Qualifications
Identity number
Employer/pharmacy
Position/job title
Name to be written on certificate
SAPC registration no (if applicable)
Address for correspondence
Male
Work:
(h) (
(
)
Tel number
Fax number
E-mail address
Female
Home:
)
(w)(
)
(cell)
Courses for which application is being made
How did you hear about Health Science Academy :
Date/s
Course
Course
Experience in this field?
1 year or less
1-3 years
3 years or more
Please indicate who should be invoiced:
Company VAT number if applicable
Payment details
Cheque
cheque attached. Value R____________
Direct deposit
(copy of deposit slip attached)
Credit Card
A copy of the back and front of your credit card is required to be faxed to:
Health Science Academy 086 298 0260 for verification
Cheques: payable to:
Health Science Academy
Bank
Branch code
First National
260950
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Account number
Health Science Academy
50631131815
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Please indicate:
If payment is done by credit card budget account, mark
period in months
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back of card
Personal requirements
Special dietary requirements?
Health Science Academy (Pty) Limited reserves the right to make changes without prior notification
I hereby apply to be enrolled in the abovementioned course. I understand that:

The fees include the assessment fee for the course where relevant (Total Quality Management course (4 months per module)).

The Fees are not refundable unless I am prevented by illness (supported by a doctor’s certificate) from completing the course or, I
have given Health Science Academy at least two weeks notice before the course commences, that I wish to cancel or substitute a
person. A fee of 50% will be charged per delegate for late cancellation or non-attendance.

If I do not attempt an assessment for any reason within the allotted time period other than sickness (supported by a doctors’
certificate), I will not be eligible for a refund of any part of the fee and that should I wish to attempt an assessment, then any
further assessment fees will be for my own account. Furthermore, should I not be competent when assessed at the first attempt,
further assessment fees will be for my own account.
I agree to the above terms and conditions governing my application and I agree to be bound by them.
_____________________
__________________
Signature of applicant
Date
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