SAQA

All qualifications and part qualifications registered on the National Qualifications Framework are public property. Thus the only payment that can be made for them is for service and reproduction. It is illegal to sell this material for profit. If the material is reproduced or quoted, the South African Qualifications Authority (SAQA) should be acknowledged as the source.

SOUTH AFRICAN QUALIFICATIONS AUTHORITY

REGISTERED QUALIFICATION THAT HAS PASSED THE END DATE:

Certificate: Pharmaceutical Production Technology: Basic Course

SAQA QUAL ID	QUALIFICATION TITLE
22999	Certificate: Pharmaceutical Production Technology: Basic Course
ORIGINATOR
Health Science Academy (Pty) Ltd
PRIMARY OR DELEGATED QUALITY ASSURANCE FUNCTIONARY			NQF SUB-FRAMEWORK
-			OQSF - Occupational Qualifications Sub-framework
QUALIFICATION TYPE	FIELD		SUBFIELD
National Certificate	Field 06 - Manufacturing, Engineering and Technology		Manufacturing and Assembly
ABET BAND	MINIMUM CREDITS	PRE-2009 NQF LEVEL	NQF LEVEL	QUAL CLASS
Undefined	120	Level 3	Level TBA: Pre-2009 was L3	Regular-Provider-ELOAC
REGISTRATION STATUS		SAQA DECISION NUMBER	REGISTRATION START DATE	REGISTRATION END DATE
Passed the End Date - Status was "Registered"		SAQA 9900/00	2003-07-01	2006-06-30
LAST DATE FOR ENROLMENT		LAST DATE FOR ACHIEVEMENT
2007-06-30		2010-06-30

In all of the tables in this document, both the pre-2009 NQF Level and the NQF Level is shown. In the text (purpose statements, qualification rules, etc), any references to NQF Levels are to the pre-2009 levels unless specifically stated otherwise.

This qualification does not replace any other qualification and is not replaced by any other qualification.

PURPOSE AND RATIONALE OF THE QUALIFICATION

Learners in the pharmaceutical industry who have completed this programme, have the education and training of pharmaceutical production technology to assist the pharmacist in the manufacture of pharmaceutical products and or intermediates of the highest possible quality.

LEARNING ASSUMED TO BE IN PLACE AND RECOGNITION OF PRIOR LEARNING

Learners who register for this qualification must have reading, writing, listening and speaking skills equivalent to grade 10, NQF level 3

RECOGNISE PREVIOUS LEARNING?

EXIT LEVEL OUTCOMES

EXIT LEVELS OUTCOMES:

The candidate will be able to:

Receive, categorise, store, issue, dispense active and non-active materials and components.

Manufacture intermediates and final product of all current acceptable dosage forms.

Perform specified in process controls.

Package pharmaceutical products into primary and secondary containers according to packaging documentation.

Investigate and report on any deviations in terms of product quality and on complaints.

Develop, write and comply with Standard Operating Procedures and write basic reports.

Collect information for research purposes.

SPECIFIC OUTCOMES:

The primary aim of pharmaceutical technologist education is to train life long learners who can assist the pharmacist in the pharmaceutical manufacturing industry to perform pharmaceutical technology processes using their knowledge, skills, technical capacity, behaviour, attitudes and integrity to ensure the manufacture of quality medicines.
On completion of the undergraduate programme, the learner must demonstrate the following knowledge, skills, applied technology, behaviour, attitudes and integrity.

Knowledge Outcomes:

Use of science and technology to manufacture and distribute final product and intermediates of all current acceptable dosage forms.

Understanding the basic principles of pharmaceutical technology processes in their environmental and social determinants

Understanding the basic principles of cGMP focussing on areas of facilities (building and equipment) manufacturing and control.

Understanding the basic principles of hygiene, cleanliness, personal health care and a healthy environment and the effect on the manufacturing of medicines.

Understanding and applying the principles of storage and distribution of medicines, intermediates, raw materials and components.

Understanding basic financial principles of cost and productivity implications in the manufacturing setting

Demonstrating the ability to identify and notify anomalies and problems that arise in the manufacturing environment

Understanding the basic principles and procedures governing data collection and application

Skills:

Basic computer skills;

Basic communication skills, interpersonal skills;

The ability to work in a multi-functional team;

Data collection and procedures, including manufacturing process control data, in process testing data, validation of manufacturing process data and working according to standard operating procedures and protocols;

Pharmaceutical manufacturing technical and workplace skills including:
o The compliance with GMP in the manufacturing setting and housekeeping;
o Assisting with receiving, categorising, storage, issue and dispensing of active and non-active raw materials and components;
o Assisting with the manufacturing of intermediates and final product of all current acceptable dosage forms;
o Performing specified in process controls and in process packaging tests at the basic level;
o Assisting in controlling printed packaging materials;
o Assisting with sampling, quarantining, managing the quarantine store
o Assisting with investigating and reporting on any deviations in terms of product quality and on complaints;
o Complying with Standard Operating Procedures and assisting with writing basic reports;
o Assisting with the completion of accountability reports including yield reconciliation;
o Assisting with the compliance of storage requirements during distribution to end customers;
o Assisting with destruction of pharmaceutical materials, components and products in compliance with regulatory and environmental requirements;
o Application of operator safety procedures according to regulatory requirements.
o Assisting with manufacturing resource planning including material requirements planning.

Attitude and behavioural outcomes:

Respect for associates and colleagues, without prejudice with regard to race, culture, gender etc.

Recognition of human and patient rights

A positive approach to self-directed life long learning.

A positive approach towards personal health care

A desire to ensure the provision of pharmaceutical products and/or intermediates of the highest possible quality.

An awareness of personal limitations and a willingness to seek help when necessary.

A positive attitude towards change and functioning within the pharmaceutical manufacturing environment

A positive attitude towards the advancement of knowledge of pharmaceutical technology

ASSOCIATED ASSESSMENT CRITERIA

Learners should provide evidence that they are competent in the following at the conclusion of the programme.

Demonstrate an understanding of the basic principles and theories of the following at the basic level:
o Good Manufacturing Practice
o Measurements
o Tablet Manufacturing
o Encapsulation
o Solutions, Suspensions and Emulsions
o Suppositories
o Topical Dosage Forms
o Sterile Manufacture
o Packaging
o Process Equipment and Factory Design

Demonstrate the ability to use dispensing equipment to dispense raw materials and use computers where appropriate for record keeping purposes at the basic level.

Demonstrate the ability to perform appropriate in process control tests on intermediates and final products of the different dosage forms at the basic level.

Describe the basic principles and requirements of standard operating procedures, basic reports, deviation reports, yield reconciliation, accountability reports.

Demonstrate the ability to assist with sampling and quarantining.

Describe the principles of manufacturing resource planning including material requirements planning.

Evidence will be given by means of evaluation and assessment utilising:
o Formal continuing evaluation (e.g. assignments)
o Formal end evaluations (e.g. theoretical written examinations)

INTEGRATED ASSESSMENT

Assessment in the programme is based on integrated and continuing assessment with due consideration of the following principles:

Learning is best achieved when the learner is able to see the relevance of the concept.

Learning is improved through reflective practice where the learner is given the opportunity to apply concepts and reflect on what has been learnt.

Learning is enhanced if the learner is provided with the opportunity for regular assessment, which informs his/her learning.

Small group discussion is an important feature of learning since it enables the learner to express doubts and build up confidence in a non-threatening environment.

Learners acquire insight into the assessment criteria which are considered important when asked to undertake their own assessment and the assessment of peers.

Assessment takes place through the assessment of the relevant unit standards and through assignments, with emphasis on continuous assessment during the learning programme

Assessment entails 3 elements:

Formal end of course assessment

Continuing formal assessment

Continuing informal assessment

Formative and Summative assessment are integrated.

The following quality assurance procedures form part of the overall evaluation and accreditation system:

Internal assessors, examiners and moderators.

External assessors, examiners and moderators.

Accreditation requirements and guidelines of the South African Pharmacy Council.

Recognition by the Medicines Control Council.

Requirements and guidelines of the further education and training quality assurance bodies. (SAQA requirements)

An internal review as part of Health Science Academy`s quality assurance systems.

ARTICULATION OPTIONS

The basic level pharmacists assistants course for industry would enable the learner to move to the community (retail), hospital or distribution sectors by the simple completion of the sector specific modules for the other sectors and also has an opportunity to enter related manufacturing industries such as the cosmetic industry

The qualifications towards which a learner may proceed, include the Advanced Course, registration as Pharmacist Assistant, pre-university bridging course and then the degree of Bachelor of Pharmacy offered at various pharmacy schools at universities in South Africa.

LEARNING PROGRAMMES RECORDED AGAINST THIS QUALIFICATION:

NONE

PROVIDERS CURRENTLY ACCREDITED TO OFFER THIS QUALIFICATION:

This information shows the current accreditations (i.e. those not past their accreditation end dates), and is the most complete record available to SAQA as of today. Some Primary or Delegated Quality Assurance Functionaries have a lag in their recording systems for provider accreditation, in turn leading to a lag in notifying SAQA of all the providers that they have accredited to offer qualifications and unit standards, as well as any extensions to accreditation end dates. The relevant Primary or Delegated Quality Assurance Functionary should be notified if a record appears to be missing from here.

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