Compliance, Audit and Validation

Overview

Are you compliant? This is a question which any Pharmaceutical, Biotechnology, Genomics, Chemical, Medical Device and Supply Chain Management company 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. Whether you are a manufacturer or a supplier, your business expansion, continual improvements and customer satisfaction rests principally on the quality standards of your business. Reg Solutions Compliance and Validation Center of Excellence (CoE) can help in this effort by assisting you with professionally aided compliance audit services for pharmaceuticals, medical devices, consumer healthcare industries such as: 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).

Reg Solutions provides Regulatory compliance services that involve evaluating your requirement and suggesting inputs to the business processes that are designed to assure customer satisfaction as well as 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.

With uniquely designed in-house and on-demand compliance best practices and Regulatory compliance management, Reg Solutions ensures 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.

Reg Solutions 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.

Reg Solutions 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 Practices 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 Practices (GMP) for Medicinal Products

• Health Canada - Health Products and Food Branch Inspectorate – GMP Guidelines

• WHO 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 GMP for Medicinal Products

Good Laboratory Practice

• ISO / IEC 17025: 2017 - 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 (GVP)

• 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

Reg Solutions Advantages

• Reg Solutions intends to provide you a competitive lead by assisting you plan and create SOPs and control manufacturing facilities.

• Integrated process model

• Maintain brand image

• Overall cost savings

• Implement effective and compliant business processes

• Establishing validation and qualification strategies