Infrastructure & ENVIRONMENT

1. Purpose

This document provides the process for Infrastructure and Environment.

This document covers the procedure for the practices that must be followed for compliance of ISO13485 

2. Approval

(Version at end of page)

Signed V13 BN 09.09.2024

3. Scope

The process covers all documents and process and products as defined in the SOP.

This Policy must be read-with and comply with the Protection of Personal Information Act 04 of 2013, ("POPI"), the Company POPI Policy, PAIA Manual and processing of personal information envisaged under this Policy must be done in accordance with the aforementioned.

4. Responsibilities

Approval: Author of the document, Henry Manyike

Changes: Author of the document, Bonang Ntuli

5. Definitions

Infrastructure - building, lights, floors, windows, perimeter, equipment relevant to the operations / SHEQ

Environment - the working condition appropriate to GMP / requirements of the product e.g. cleanliness, storage conditions

Rework - the action of redoing a production procedure for an item / batch in order to correct a defective / faulty aspect/s (eg: packaging /  labelling / out of specification) mainly in regards to disposable products

Infrastructure Repair - is to restore (something damaged, faulty, or worn) to the original safety and performance condition to put the item back into acceptable working order again

Infrastructure Maintenance - this is required for preserving the condition of an item (infrastructure, machinery) 

6. Abbreviations

GMP - Good manufacturing, distribution, storage, stock management practices

SHEQ - Safety, Health, Environment and Quality

NCCA – Non Conformance Corrective Action

SOP – Standard Operating Procedure

7. References

ISO13485 Clause 6.3 Infrastructure & 6.4 Work environment

SOP Non-Conformance, Deviations and Concessions & Corrective Action 

8. Procedure

8.1 Infrastructure & Environment

Hygiene Areas 

Picture - Decontamination Area in JHB (top) ; Areas to be used only with the required hygiene and PPE garments and no general walk through of goods; RED boundary for GMP hygiene and GREEN boundary for Good HYGIENE practices.

Note: Capetown facility follows through a QA agreement with a share site arrangement

8.2 Maintenance

• 1. Under Infrastructure and Environment the organization provides requirements for the maintenance activities, including the interval of performing the maintenance activities, when such maintenance activities, or lack thereof, can affect product quality. As appropriate, the requirements apply to equipment used in operation, the control of the work environment and monitoring and measurement and records of such maintenance are maintained.

  2. Work environment and contamination control follows above however if any maintenance, or preventative maintenance of furnishings, fittings or equipment is required, then it is to be reported to the General Manager or Warehouse Manager in order for the maintenance to be arranged. 

  3. This preservation includes identification, handling, packaging, storage, and protection and also applies to the basic parts of a product

  4. Supplier are approved by SOP External Providers 

  5. Preventive maintenance activities include equipment , vehicles, computers, facility checks by management on a regular basis. The ideal preventive maintenance program would prevent all equipment failure before it occurs. 

Maintenance requirements: -

In the event of and non conformance finding then SOP Non-Conformance, Deviations and Concessions & Corrective Action SOP is followed  

8.3 Control of Monitoring and Measuring Equipment (7.6)

1. Where there is monitoring and measurement undertaken, the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements.

2. The  procedure to follow to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements is as per the planned maintenance below.

3. As necessary to ensure valid results, measuring equipment is to:

   • a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards: when no such standards exist, the basis used for calibration or verification is recorded.

   • b) be adjusted or re-adjusted as necessary: such adjustments or re-adjustments shall be recorded

   • c) have identification in order to determine its calibration status;

   • d) be safeguarded from adjustments that would invalidate the measurement result;

   • e) be protected from damage and deterioration during handling, maintenance and storage.

4. Calibration or verification is performed as detailed in the table below.

   •  In addition, the validity of the previous measuring results are assessed and recorded when the equipment is found not to conform to requirements. 

5. Appropriate action is taken in regard to the equipment and any product affected and SOP Non-Conformance, Deviations and Concessions & Corrective Action is followed.

6. Monitoring and measurement software is used for Temperature Monitoring and Access Control

• 1. As required,  procedures for validation of the application of computer software used for the monitoring and measurement of requirements is reported. Such software applications is to be validated prior to initial use and, as appropriate, after changes to such software or its application.

  2. The specific approach and activities associated with software validation and re-validation is to be proportionate to the risk associated with the use of the software, including the effect on the ability of the product to conform to specifications.

9. Risk Based Approach

In the event of non compliance follow SOP  NON CONFORMANCE CORRECTIVE ACTION

Risk Based Approach Report

[Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT   refer Document]

9.1 Trend Analysis and Continual Improvement

An analytical review is reported monthly to management and this forms part of the input through Data Analysis to management review 

The Trend should pick up any potential and recurring incidents, where corrective action must be reported at the management review to facilitate continual improvement.

10. Revision History

Revision 13, 09.09.2024 - BN - Point 8.1 - 8.2 correction of office layout

Revision 12, 29.04.2024 - BN - Point 8.1 - 8.2 correction of docs

Revision 11, 20.09.2022 - NT - Point 5 correction of definitions and point 8.1 detail of CTN sharing site arrangement

Revision 10, 26.05.2022 - NT - changing color font to black on 8.1 & 8.3.6 and approval by HM

Revision 9, 15.12.2021 - NT - adding the Layout - Ground Floor Plan

Revision 8, 16.11.2021 - NT - signed off from TNA

Revision 7, 27.08.2021 - TNA - updating responsibilities / addition of 4 new definitions

Revision 6, 04.02.2021 - TNA - New format with Responsibilities, Risk based approach, Approval and Records added and new google site format.   Amending links and forms

Revision 5, Digitally signed on 15.10.2020 by NT

Revision 1-4, unknown due to google site change to new google site

11. Records

Name Retained by/ in Retention period Hard copies Destroyed by

None             n/a               n/a         n/a