1. WHO WE ARE :
We are Pharmaceutical GMP Compliance Auditors and Subject Matter Experts (SME) in Pharmaceutical Quality Management Systems.
2. WHO WE SERVE :
We serve the pharmaceutical and biopharmaceutical manufacturing industries.
3. WHAT WE DO :
1. We prepare and supply GMP Compliance Auditing Risk Assessment Templates for :
Pharmaceutical Chemistry and Microbiology Laboratories, Pharmaceutical Production and Warehouse Departments, Pharmaceutical Quality Assurance and Validation Departments.
2. We prepare and supply GMP Compliant Job Descriptions for
Pharmaceutical Senior Management :
Site Responsible Pharmacist, Quality Assurance Manager, Quality Control Laboratory Manager, Production Manager, Warehouse Manager, QA Validations Manager, Packaging Manager, GMP Compliance Manager, Quality Systems Manager and Pharmaceutical Staff.
3. We prepare and supply GMP Auditing SOP's for Pharmaceutical Quality Management Systems :
Product Quality Review, Change Control, Management Review, Corrective and Preventive Action (CAPA), Good Data Integrity Practices, Good Documentation Practices, Quality Risk Management, Complaints and Product Recall, Self-Inspections, Deviation Handling, Laboratory OOS Results System, Vendor and Supplier Qualification
4. We prepare and supply Pharmaceutical GMP Compliance Documentation Templates for :
Process Validation Protocol, Cleaning Validation Protocol, Packaging Validation Protocol, Equipment Requalification Protocol, Product Stability Testing Protocol.
4. HOW WE DO IT
We conduct online GMP Auditing and GMP Compliance Gap Analysis
Studies with the client.
5. THE RESULTS :
• SAHPRA GMP Manufacturing Licence Application Approval and Renewal
• WHO Prequalification Programme of Laboratories Certification
• ISO 17025 Laboratory Standard Accreditation and Certification
• PIC/S GMP Manufacturing Licence Application Approval and Renewal
6. CONTACT US :
Email Address : drphyleeps@yahoo.com
Company Details
- Founded
- -
- Address
- Midrand, Johannesburg, South Africa, Za
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Keywords
- Pharmaceutical GMP Compliance Auditing, Pharmaceutical GMP Compliance Gap Analysis Studies, Pharmaceutical GMP Compliance Policy Implementation, Pharmaceutical GMP Compliance Risk Assessments, 5P’s of Pharmaceutical GMP Compliance Model, US FDA Six Systems Inspection Model, Pharmaceutical Product Quality Reviews, Pharmaceutical Process Validation Protocol Writing, Pharmaceutical Cleaning Validation Protocol Writing, Laboratory OOS Results Investigation Protocol Writing, Pharmaceutical Equipment Requalification Protocol Writing.
- HQ
- Midrand, Johannesburg, South Africa
Pharmacompliance Gmp Auditors Questions
Pharmacompliance Gmp Auditors's LinkedIn profile is https://za.linkedin.com/company/pharmacompliance-gmp-auditors
Pharmacompliance Gmp Auditors's industry is
Pharmaceutical Manufacturing
Pharmacompliance Gmp Auditors's top competitors are
Obel Labs South Africa,
Afrasia Health,
Reitzer Healthcare,
Phenomena Pharma,
Rld Consulting Services,
Eurolab (Pty) Ltd.,
Sa-Labs,
Gauteng Software Laboratories,
Medicolab Cc,
Mn Validation Solutions Pty Ltd.
Pharmacompliance Gmp Auditors's categories are Pharmaceutical Manufacturing
Pharmacompliance Gmp Auditors's founding year is 2020
