| (a) |
Pre-packing entails the repacking of medicines from bulk packs into smaller packs suitable for patient use and must be performed in terms of the provisions of the Medicines Act and in accordance with Good Manufacturing and Distribution Practices as determined by the MCC as well as the standards provided below. |
| (b) |
Pre-packing may only be performed by a pharmacist or under the supervision of a pharmacist under strictly controlled conditions and according to a clearly designed system of quality assurance based on the standards provided in this document and the General Regulations published in terms of the Medicines Act. |
| (c) |
Where tablets are pre-packed they must be manually counted, weighed, or electronically counted. Measuring by volume is not permitted. |
| (d) |
Pre-packing must take place only under the required conditions of temperature and humidity. |
| (e) |
A batch numbering system must be used which gives ready access to all information required to ascertain the ingredient(s) and the procedure(s) used in preparing the finished product. |
| 2.19.1 |
Minimum standards for pre-packing |
To comply with the above requirements, the following minimum standards must be complied with in the packaging of medicines in patient-ready packs:
| (a) |
All pre-packing operations must be confined to a separate area intended for such purposes and physically partitioned off from all other working areas, with limited access. |
| (b) |
The pre-packing area must be effectively lit and ventilated with temperature and humidity control facilities. Conditions must be such that there is no adverse effect on the product or equipment either directly or indirectly. |
| (c) |
All equipment must be kept clean and before each production run checked for efficiency and accuracy. |
| (d) |
Electronic tablet counters must preferably be fitted with dust covers and extractor fans. |
| (e) |
The personnel operating the equipment must be competent to do so and appropriately registered with Council (i.e. pharmacist's assistants). |
| (f) |
Personnel must be adequately protected from possible exposure to health hazards (e.g. oncolytics, penicillin, etc.) |
| (g) |
A master pre-packing document must be compiled for each product to be packed, specifying the following: |
| (i) |
the name of the product; |
| (ii) |
a description of its pharmaceutical form and strength; |
| (iii) |
the pack size expressed as quantity of product in the final container; |
| (iv) |
a complete list of packaging materials required; and |
| (v) |
the method of packaging as well as the speed of the turntable and vibrator where applicable. |
| (h) |
A batch number must be assigned to each batch of medicine packed. |
| (i) |
A packaging record must be kept for each batch of medicine packed for a period of three years. The following details must appear on the packaging record: |
| (i) |
the name of the product; |
| (ii) |
the strength and dosage form of the product; |
| (iii) |
the name of the manufacturer; |
| (v) |
the manufacturer's batch number; |
| (vi) |
the assigned packaging batch number; |
| (vii) |
the date of packaging; |
| (viii) |
the allocated expiry date; and |
| (ix) |
a sample of the label and plastic bag used. |
| (j) |
Attention must be given to the security of all stored labels, plastic bags and pre-printed material to prevent a possible mix-up between packaging material. |
| (k) |
Any unused, damaged or unacceptable labels or plastic bags bearing a particular batch number and packaging date must be discarded after annotating the number thereof on the packaging record. |
| (l) |
The following information must appear on all labels/plastic bags: |
| (i) |
the delegated packaging batch number and/or packaging date as required; |
| (ii) |
the approved name of the substances where applicable; |
| (iv) |
the quantity or volume of medicine; |
| (vi) |
the name and address of the packaging institution; and |
| (vii) |
any necessary additional information, e.g. storage conditions, warnings, etc. |
| (m) |
Space on the label must be provided for; |
| (i) |
the directions for use; |
| (ii) |
the name and reference number of the patient; and |
| (iii) |
the name and address of the hospital. |
| (n) |
Containers and packaging material must conform to the following requirements: |
| (i) |
protecting the product from light and moisture; |
| (ii) |
preventing contamination of the product, including possible microbial contamination; and |
| (iii) |
prevention of product deterioration. |
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