Overview

Are you compliant? This is a question which Pharmaceutical, Biotechnology, Genomics, Chemical, Medical Device and Supply Chain Management companies find challenging to answer. It is mandatory for these organizations to comply with stringent Quality, Safety, and Regulatory requirements in each geography where the products are distributed. The current trend is moving towards a worldwide harmonization of Quality and Safety with Customer and your Business requirements. Whether you are a manufacturer or a supplier to the Pharmaceutical/Medical Device/Biotechnology Industry, your business expansion, continual Improvements and customer satisfaction rests principally on you. Freyr’s Compliance and Validation Center of Excellence (CoE) can help in this effort by assisting you in cGMP (Current Good Manufacturing Practices), GCP (Good Clinical Practice), GDP (Good Distribution Practice), Good Laboratory Practice (GLP), GPVP (Good Pharmacovigilance Practice) and your GxP Computer System Validation (CSV).

At Freyr, our teams have extensive domain understanding and hands-on experience on execution of industry specific compliance requirements to assist you in the designing, development, implementation, and integration of all your Regulatory, Quality and business needs on a unified platform. 

We will evaluate your requirement and suggest inputs to the business processes that are designed to assure customer satisfaction as well as Regulatory compliance. With our audit preparation and readiness strategies, we provide audit (gap analysis) report along with suggested actions for corrective and preventive actions (CAPA) to avoid potential 483s and audit findings from regulators.

Freyr performs around 700 checks at a preliminary level spread across 18-19 GMP functional areas
Freyr performs around 700 checks at a preliminary level spread across 18-19 GMP functional areas

We ensure that all your processes and products are aligned with applicable quality, information security, compliance and regulatory requirements such as (but need not be limited to) the following

 

Freyr Expertise

Quality and Regulatory compliance – Current Good Manufacturing Practices (cGMP)

  • ISO 9001: 2015 Quality Management Systems - Requirements
  • United States Food and Drug Administration (US FDA) 21 CFR 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
  • United States Food and Drug Administration (US FDA) 21 CFR 820: Quality System Regulation
  • European Commission EudraLex – Volume 4 – Guidelines for Good Manufacturing Practices for Medical Products for Human and Veterinary Use
  • EU (2003/94/EC Part I, II, III)
  • PIC/S Guide to Good Manufacturing Practice for Medicinal Products
  • Health Canada - Health Products and Food Branch Inspectorate – Good Manufacturing Practices Guidelines
  • WHO Good Manufacturing Practices (GMP) for active pharmaceutical ingredients
  • Applicable ICH guidelines
  • ISO 13485:2016: Medical Devices Quality Management System
  • CE Marking
  • Saudi Food and Drug Authority (SFDA) Guidelines: Guide to Good Manufacturing Practice for Medicinal Products

Good Laboratory Practice

  • ISO / IEC 17025: 2005 - General Requirements for the Competence of Testing and Calibration Laboratories
  • OECD (Organization for Economic Co-operation and Development) - Guidelines of Good Laboratory Practice
  • EURACHEM / CITAC Guide: Guide to Quality in Analytical Chemistry - An Aid to Accreditation, 3rd Edition (2016) should be followed in analytical procedures.
  • 21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies
  • Guide to UK GLP Regulations, Feb 2000 (by GLPMA)
  • WHO Handbook on Good Laboratory Practice (GLP): Quality practices for Regulated Non-Clinical Research and Development
  • Health Canada: Finalized Guidance Document - Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice.
  • OSHA (Occupational Safety and Health Administration) standards
  • Applicable ICH guidelines

Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPVP)

  • ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice - E6
  • E2B(R3) Individual Case Safety Report (ICSR) Specification and Related Files
  • E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER)
  • Other applicable ICH guidelines
  • Guidelines on good pharmacovigilance practices (GVP)  Modules
  • FDA Safety Reporting Requirements for INDs and BA/BE Studies
  • Post Marketing Safety Reporting for Human Drug and Biological Products Including Vaccines
  • FDA Regional Implementation Specifications for ICH E2B(R3) Reporting to the FDA Adverse Event Reporting System (FAERS)
  • Providing Submissions in Electronic Format – Post Market Non-Expedited ICSRs Technical Questions and Answers
  • E2E Pharmacovigilance Planning

Information Security, Data Privacy and Computer System Validation (CSV)

  • ISO 27001: 2013 Information Technology – Security Techniques – Information Security Management System – Requirements
  • ISO 27002: 2013 Information Technology – Security Techniques – Code of Practice for Information Security Management.
  • USFDA 21 CFR Part 11: Electronic Records; Electronic Signatures – Scope and Application
  • EU GMP guide Annex 11
  • Japanese ERES Guideline Notification No 0401022
  • GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems 
  • USFDA – Software Validation Guidelines
  • Applicable ICH QSEM guidelines
 

Freyr Advantages

Freyr intends to provide you a competitive lead by assisting you plan, create, and control manufacturing facilities. With our expertise, you can be profited in following aspects:

  • Integrated process model
  • Maintain brand image
  • Overall cost savings
  • Implement effective and compliant business processes
  • Establishing validation and qualification strategies