Repository

ABioSA Guides

Supporting Documents - Guide Good Manufacturing Practices

01-GMP-Toolkit-Narrative.pdf, pdf (153 KB)
02-GMP-SOP-04-Maintenance-of-Equipment.docx, docx (32 KB)
02-GMP-SOP04-Form01-List-of-Equipment-Requiring-Maintenance.doc, doc (44 KB)
02-GMP-SOP04-FORM02-Maintenance-Log.doc, doc (48 KB)
02-GMP-SOP04-Form03-Calibration-Status-of-Instrument-and-Equipment.doc, doc (47 KB)
03-GMP-SOP-07-Handling-of-Finished-Products.docx, docx (33 KB)
04-Gap-Analysis-and-Self-Assessment_Checklist-ISO-22716-2017-GMPs-Guideline.docx, docx (61 KB)
05-GMP-SOP-015-Internal-audit.docx, docx (33 KB)
05-GMP-SOP015-Form01-Annual-Internal-Audit-Calendar.doc, doc (33 KB)
05-GMP-SOP015-Form02-Internal-Audit-Findings-Notification.doc, doc (34 KB)
06-GMP-Form-SOP01-001-Job-Description-Matrix.doc, doc (50 KB)
06-GMP-Form-SOP01-002-List-of-Personnel.doc, doc (73 KB)
06-GMP-Form-SOP01-003-In-house-Attendance-Record.doc, doc (41 KB)
06-GMP-Form-SOP02-002-Visitors-Entry-Form.doc, doc (43 KB)
06-GMP-SOP-01-Personnel-and-Training.docx, docx (31 KB)
06-GMP-SOP-02-Personnel-Hygiene-and-Health.docx, docx (31 KB)
07-GMP-SOP_03-01_Checklist_for_premises.doc, doc (46 KB)
07-GMP_SOP-03-Premises.docx, docx (31 KB)
08-GMP-SOP-013-Product-Complaints-and-Recall.docx, docx (34 KB)
08-GMP-SOP013-Form-01-Customer-Complaint-Form.doc, doc (30 KB)
08-GMP-SOP013-Form-02-Complaint-Summary-Report.doc, doc (58 KB)
09-GMP-SOP-08-Quality-Control-Laboratory.docx, docx (33 KB)
10-Hazard-Analysis-Worksheet.doc, doc (56 KB)
10-Quality-Management-System-Manual.doc, doc (100 KB)
11-GMP-SOP-05-Handling-of-Raw-Materials-and-Packaging-materials.docx, docx (34 KB)
11-GMP-SOP05-Form-01-Approved-List-of-Suppliers.doc, doc (37 KB)
11-GMP-SOP05-Form-02-Disposal-of-Non-conforming-Product.doc, doc (35 KB)
11-GMP-SOP05-Form-03-Daily-Stock-Statement.doc, doc (45 KB)
11-GMP-SOP05-Form-04-Incoming-Material-Inspection-Record.doc, doc (36 KB)
12-GMP-Toolkit-References.pdf, pdf (88 KB)
13-GMP-SOP-11-Managing-of-Subcontracted-Activities.docx, docx (32 KB)
14-GMP-SOP-09-Treatment-of-product-that-is-out-of-specification.docx, docx (32 KB)
15-GMP-SOP-10-Handling-Storage-and-Disposal-of-Wastes.docx, docx (30 KB)
16-GMP-SOP-014-Change-Control.docx, docx (31 KB)
16-GMP-SOP014-Form-01-Managing-of-Change-Request.docx, docx (18 KB)
17-GMP-SOP-016-Documented-information-and-Records.docx, docx (34 KB)
17-GMP-SOP016-Form-01-Master-List-of-QMS-Documents-and-Records.doc, doc (43 KB)
17-GMP-SOP016-Form-02-Document-Addition-or-Change-Request.doc, doc (32 KB)
17-GMP-SOP016-Form-3-Document-Withdrawal-Notice.doc, doc (33 KB)

Events/ Workshops

Biotrade Stakeholder Forums (October 2018-November 2020)

Trainings

EU market access and compliance - ABioSA/Lisam webinars (August 2021)

Good Manufacturing Practices (with supporting documents)

01-GMP-Toolkit-Narrative.pdf, pdf (153 KB)
02-GMP-SOP-04-Maintenance-of-Equipment.docx, docx (32 KB)
02-GMP-SOP04-Form01-List-of-Equipment-Requiring-Maintenance.doc, doc (44 KB)
02-GMP-SOP04-FORM02-Maintenance-Log.doc, doc (48 KB)
02-GMP-SOP04-Form03-Calibration-Status-of-Instrument-and-Equipment.doc, doc (47 KB)
03-GMP-SOP-07-Handling-of-Finished-Products.docx, docx (33 KB)
04-Gap-Analysis-and-Self-Assessment_Checklist-ISO-22716-2017-GMPs-Guideline.docx, docx (61 KB)
05-GMP-SOP-015-Internal-audit.docx, docx (33 KB)
05-GMP-SOP015-Form01-Annual-Internal-Audit-Calendar.doc, doc (33 KB)
05-GMP-SOP015-Form02-Internal-Audit-Findings-Notification.doc, doc (34 KB)
06-GMP-Form-SOP01-001-Job-Description-Matrix.doc, doc (50 KB)
06-GMP-Form-SOP01-002-List-of-Personnel.doc, doc (73 KB)
06-GMP-Form-SOP01-003-In-house-Attendance-Record.doc, doc (41 KB)
06-GMP-Form-SOP02-002-Visitors-Entry-Form.doc, doc (43 KB)
06-GMP-SOP-01-Personnel-and-Training.docx, docx (31 KB)
06-GMP-SOP-02-Personnel-Hygiene-and-Health.docx, docx (31 KB)
07-GMP-SOP_03-01_Checklist_for_premises.doc, doc (46 KB)
07-GMP_SOP-03-Premises.docx, docx (31 KB)
08-GMP-SOP-013-Product-Complaints-and-Recall.docx, docx (34 KB)
08-GMP-SOP013-Form-01-Customer-Complaint-Form.doc, doc (30 KB)
08-GMP-SOP013-Form-02-Complaint-Summary-Report.doc, doc (58 KB)
09-GMP-SOP-08-Quality-Control-Laboratory.docx, docx (33 KB)
10-Hazard-Analysis-Worksheet.doc, doc (56 KB)
10-Quality-Management-System-Manual.doc, doc (100 KB)
11-GMP-SOP-05-Handling-of-Raw-Materials-and-Packaging-materials.docx, docx (34 KB)
11-GMP-SOP05-Form-01-Approved-List-of-Suppliers.doc, doc (37 KB)
11-GMP-SOP05-Form-02-Disposal-of-Non-conforming-Product.doc, doc (35 KB)
11-GMP-SOP05-Form-03-Daily-Stock-Statement.doc, doc (45 KB)
11-GMP-SOP05-Form-04-Incoming-Material-Inspection-Record.doc, doc (36 KB)
12-GMP-Toolkit-References.pdf, pdf (88 KB)
13-GMP-SOP-11-Managing-of-Subcontracted-Activities.docx, docx (32 KB)
14-GMP-SOP-09-Treatment-of-product-that-is-out-of-specification.docx, docx (32 KB)
15-GMP-SOP-10-Handling-Storage-and-Disposal-of-Wastes.docx, docx (30 KB)
16-GMP-SOP-014-Change-Control.docx, docx (31 KB)
16-GMP-SOP014-Form-01-Managing-of-Change-Request.docx, docx (18 KB)
17-GMP-SOP-016-Documented-information-and-Records.docx, docx (34 KB)
17-GMP-SOP016-Form-01-Master-List-of-QMS-Documents-and-Records.doc, doc (43 KB)
17-GMP-SOP016-Form-02-Document-Addition-or-Change-Request.doc, doc (32 KB)
17-GMP-SOP016-Form-3-Document-Withdrawal-Notice.doc, doc (33 KB)

ABioSA stakeholder mapping of public and business support organisations