Pharmacy Wholesale
1.Purpose
This document provides the process for Product, Premises, facilities and Utilities observed good distribution practices for cleanliness, Hygiene and safety and controlled infrastructure and environment for distribution practices
This document covers the procedure for the practices that must be followed for Product, Premises, facilities and Utilities cleanliness, Hygiene and safety including Pest Control and Waste management in compliance of ISO13485
2. Approval
(Version at end of page)
Signed V3 SCR 39.03.2023
3. Scope
The process covers all documents, process and products for Medicines as define in the SOP
4. Responsibilities
Approval & Changes of the document, Simone Rudolph-Shortt (RP)
5. Definitions
Cleanliness - Good Hygiene Practices within the Facility, infrastructure and environment and Personal Hygiene to ensure the product is preserved and protected from contamination
“Standard Operating Procedure (SOP)” an authorized, written procedure giving instructions for performing operations not necessarily specific to a given product but of a more general nature (e.g. equipment operation, maintenance and cleaning, validation, cleaning of premises and environmental control, sampling and inspection);
6. Abbreviations
SHEQ - Safety, Health, Environment and Quality
NCCA – Non Conformance Corrective Action Record
SOP – Standard Operating Procedure
DoC – Declaration of Conformity
COA – Certificate of Analysis
HPCSA - Health Professions Council of South Africa
SAPC - South African Pharmacy Council
7. References
ISO13485 Clause 6.3, 6.4
as detailed below
8. Procedure
refer GWP
Pharmacy.docx
4.02 SA Guide to GWP v2 Oct2011 for comment.doc March 2012
(1) How to create, review and update SOPs; refer DOCUMENTATION
(2) Preparation of Site Master File; refer current SMF as a format which covers approvals, revision and update
(3) Contract/service level agreement activities; refer EXTERNAL PROVIDERS
(4) Responsibilities and job descriptions; refer Quality Manual section 8.4.6 Roles & Responsibilities
(5) Delivery and transportation; refer WAREHOUSE section 8.6 Incoming and out going goods
(6) Advertising and promotions control; refer PROMOTIONAL AND TRAINING MATERIAL APPROVAL
(7) Handling of technical complaints; refer COMPLAINTS
(8) Handling of Adverse drug reactions reporting; REFER ADVERSE INCIDENT
(9) Handling of Temperature deviations; refer WAREHOUSE section refer Quality Manual section 8.4.6 Roles & Responsibilities
(10) Handling of and requests for Change control; refer CHANGE CONTROL
(11) Procurement of pharmaceutical products; refer EXTERNAL PROVIDERS and 8.5.1 QA Agreements
(12) Good housekeeping/sanitation practices; refer CLEANLINESS
(13) Conditions of employment; refer refer Quality Manual section 8.4.6 Roles & Responsibilities
(14) Performing and closing out of Self-inspections (OOS); refer NCCA
(15) Receipt of stock; refer EXTERNAL PROVIDERS 8.6 Verification of Purchased Product (7.4.3) and WAREHOUSE section 8.6 Incoming and out going goods and
(16) Storage of pharmaceutical products; refer WAREHOUSE and layout INFRASTRUCTURE
(17) Control of pharmaceutical products in quarantine; refer WAREHOUSE section
(18) Products that require special storage/ handling instructions; refer (16)
(19) Cold chain management; not applicable
(20) Control of counterfeit pharmaceutical products;
20.1 Any counterfeit or suspected pharmaceutical product found in the pharmaceutical supply chain is segregated, sealed and clearly labelled quarantined goods.
20.2 Suspected cases of counterfeit pharmaceutical products are clearly documented and the Medicines Control Council and South African Police Force will be informed without delay through contact from the SAHPRA website.
20.3 The Responsible Pharmacist follows SOP NCCA for a preliminary investigation and record as much relevant information as possible e.g. the driver’s names and ID, the vehicle registration and any other information deemed to be relevant to the investigation.
20.3 The products are clearly labelled "COUNTERFEIT" with a sticker and placed in Quarantine area, by the pharmacist, to prevent further distribution or sale.
20.4 Upon confirmation of the product being counterfeit, a formal decision is taken on its disposal and the decision recorded as part of CAPA through SOP NCCA .
(21) Rodent and pest control; refer CLEANLINESS
(22) Training/keeping training records; refer TRAINING
(23) Distribution control;
23.1 “distribution” means the procuring, purchasing, holding, storing, selling, supplying, importing, exporting, or movement of pharmaceutical products, with the exception of the dispensing or providing pharmaceutical products directly to a patient or his or her agent;
23.2 “finished product” is products which has undergone all stages of production, including packaging in its final container;
23.3 “first expiry/first out (FEFO)” that the stock with the earliest expiry date is distributed and/or used before an identical stock item with a later expiry date is distributed and/or used;
(24) Cleaning of spillages; refer CLEANLINESS refer instruction PHARMACY OPERATIONS - SPILLS SAHP03
24.1 The cleanup of any spillage to ensure complete removal of any risk of contamination, with Occupational health and safety applied, which is followed under supervision of a pharmacist and the cleaning debris is segregated for certified disposal .
24.2 Spillages should be cleaned as soon as possible to prevent possible contamination, cross-contamination and hazards. Written procedures should be in place for the handling of such occurrences. Spillages must be reported to the Responsible Pharmacist for immediate action.
24.3 Transportation and goods in transit;
(26) Vehicle cleaning;
(27) Vehicle maintenance;
(28) Delivery protocol;
(29) Delivery debrief;
(30) Loading of vehicles;
(31) Vehicle monitoring refer WAREHOUSE
(32) Vendor verification; refer EXTERNAL PROVIDERS and PHARMACY OPERATIONS- STOCK SAPH01
(33) Customer verification; refer PHARMACY OPERATIONS- ORDER SAPH02
(34) Control of returned, damaged, rejected goods; refer WAREHOUSE
(35) Storage of “Specified” Schedule 5 and Schedule 6 medicines; not applicable
(36) Destruction of expired/ damaged/ contaminated stock; refer WAREHOUSE
36.1 All stock is checked regularly for obsolete and shorted dated stock items. All due precaution is observed to prevent the issue of such short dated or expired stock
(37) Destruction of “Specified” Schedule 5 and Schedule 6 medicines; not applicable
(38) Effective stock rotation of pharmaceutical products;
(39) Stock control;
38 / 39.1 “first in/ first out (FIFO)” that the oldest stock is distributed and/or used before a newer and identical stock item is distributed and/ or used;
38/39.2 “first in/ last out (FILO)” means a distribution procedure whereby products are stored systematically on a first-in/last-out (FILO) basis;
38/9.3 Checks are done by the pharmacist to ensure effective stock rotation. Pharmaceutical products due to expire first are sold and/or distributed in accordance with the first expiry, first out (FEFO) principles. Where no expiry dates exist for the pharmaceutical products, the first in, first out (FIFO) principle is applied.
(40) Recall/ withdrawal of pharmaceutical products; refer RECALL
(41) Warehouse and refrigerator temperature monitoring, recording and control; not applicable
(42) Calibration of measuring devices; refer INFRASTRUCTURE
(43) Risk management; refer PREVENTIVE ACTION
(44) Access to warehouse in an emergency situation; refer CLEANLINESS
Access control from BST Technology, provides for staff access with a code to the Unit 1 and there is an emergency set of keys with the Finance Manager in a Key holder locked unit in the event of an emergency situation
(45) Health and safety; refer HEALTH & SAFETY
(46) Security of personnel, pharmaceutical products; refer WAREHOUSE
The Facility has onsite security through a contract with Marshall Security, with a gate guard requiring Visitor logging, and alarm system. Access is controlled refer above point 44. The Responsible Pharmacist is the holder of the keys for the Pharmacy. The Pharmacy is only accessed when the Responsible Pharmacist, or Locum, is present
(47) Warehouse fire safety; refer WAREHOUSE
(48) Waste disposal; refer WAREHOUSE
(49) Personal hygiene. refer CLEANLINESS
Risk Based Approach
In the event of non compliance follow SOP NON CONFORMANCE CORRECTIVE ACTION
[Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT refer Document]
Revision History
Revision 3; new 08.07.2021 points 44 & 46 expanded on detail of Security and Access Control
Revision 2; 25.05.2022 SCR (RP) inclusion of specific PROCESSES
Revision 1; new 08.07.2021