Good Manufacturing Practices for Manufacturing

 Quality Auditing Services for the Food & Pharmaceutical Industry

QA AND GMP CONSULTING

By Leveraging SeerPharma's extensive experience in the industries we advise, our clients can benefit from our ability to quickly understand problem areas and provide practical, actionable advice. With our deep knowledge of all relevant industry regulations and guidelines, we help customers like you implement effective and our GMP Consultants business practices and improve overall performance.

General Quality Assurance and GMP Compliance Concerns

Computer System Validation (Including CSVMP and Establishment of Infrastructure Qualification Framework)

Desktop Audit

Facility Design Review for GMP Compliance

Supplier Contract Review

Virtual GMP Training

Codes and regulations such as:

Pharmaceutical Guide to Inspection Cooperation Program on Good Manufacturing Practice for Pharmaceuticals (PIC/S Guide to GMP) PE 009

European Union (EU) GMP Guidelines (EudraLex – Volume 4)

Federal Code of Regulations (CFR) Title 21, Part 11, 210, 211

Australian Good Manufacturing Practice (Human Blood, Blood Components, Human Tissue and Human Cell Therapy Products)

Australian Standard Good Manufacturing Practice for Veterinary Chemicals

Australian Standard Good Wholesale Practice Schedules 2, 3, 4 and 8

 

Regulatory bodies such as:

The Therapeutic Goods Administration (TGA) of Australia

Medsafe of New Zealand

Health Sciences Authority (HSA) of Singapore

Food and Drug Administration (FDA) of the United States )

UK Medicines and Healthcare products Regulatory Agency (MHRA)

 

Quality Standards and guidelines such as:

ISO 9001: Quality management systems - Requirements

ISO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes

ICH Quality Guidelines

ICH Q9 Quality Risk Management

ICH Q10 Pharmaceutical Quality System

Products (Including Software)

Pharmaceutical Products (all dosage forms, sterile and non-sterile)

Medical Devices, Software as Medical Devices (SaMD), In Vitro Diagnostic Devices

Biologics

Cell, Blood, and Tissue Therapies

Software Products

Quality Management Systems (QMS)

Learning Management Systems “LMS”

Laboratory Information Management Systems (LIMS)

Enterprise Resource Planning (ERP) or Material Resource Planning (MRP)

Manufacturing Execution System (MES)