Consulting in Pharmaceutical GXP Compliance and Validation

21 CFR Part 210/211 - Good Manufacturing Practices; 21 CFR Part 820 - Medical Device Regulations; 21 CFR Part 11 - Electronic Signatures and Electronic Records

Serving the Pharmaceutical, Biotech, and Manufacturing Industries with quality, compliance, validation, and process excellence consulting.

I.     Company Overview

The Compliance Group, Inc. specializes in consulting throughout FDA regulated areas within the Pharmaceutical Environment to include: Compliance Audits, Remediation, Quality Systems Regulations, Cleaning Validation, and Computerized Systems Validation and Qualification of Equipment & Utilities, Environment, and much more.

II.    Our Mission Statement

The Compliance Group, Inc. is dedicated to: 1.) consulting in developing refined quality systems integrated with step-by-step methodology; 2.) consulting in integrating corporate policies and sustainable compliance in the validation lifecycle of computerized systems, Part 11 regulated areas, and the compliance arena; and 3.) to provide the quality and endless resources to complete any project, deliverable or remediation work on time and of the highest quality.

Our team of consultants have developed and implemented many company wide systems to assure compliance. Our extensive database includes formats and templates to get the project off and running and maximize the efficiency in development. Our expert consulting staff is ready to implement and assist you in the following areas:

III.  Management

The Compliance Group, Inc. has a dedicated team specilized in management consulting. Our consulting approach includes supply chain management associated with FDA and EMEA compliance. Our Project Management team are experienced in the FDA's New Systems Review Approach. Our management consulting team is available to:

independently managing our experienced team,

and

to work with your current project team to assure compliance, communication and proper project management through those critical paths.

Our management consultants and project management team utilizes:

-    Defined Project Plan for Critical Paths

-    Roles and Responsibility

-    Project Origination Flow Diagram

-    Detailed Schedules, Project Tracking and Resource Loading

-    Defined Project Milestones

-    Project Reporting (Weekly Progress Reports & Monthly Executive Reports)

IV.   Compliance

The Compliance Group, Inc. was founded to provide consulting services in regulatory compliance and technical expertise to manufacturers of Drug Products, and Medical Devices. With our extensive consulting experience in the Pharmaceutical Processes, Quality Assurance and Regulatory Affairs, we assist companies to comply with FDA and EMEA regulations. The Compliance Group, Inc. provides hands-on expertise in Product and Process Development, Validation and Compliance Programs.

If your business is R&D, pilot-scale, or full-scale production, you can benefit from the our broad experience in regulatory compliance and our compliance program for FDA and EMEA Regulated areas. Some of the areas we can assist you in are listed below:

1.   FDA / EMEA Liaison Activities

Assistance with responding to FDA Warning Letters, FDA 483s, and Implementation of Corrective Action Programs.

2.   Regulatory Compliance Assessments / Audits

Our regulatory compliance consulting and standards for assessments and audits follow a defined path:

a.   The creation of a regulatory reference list defining the agencies and applicable laws, regulations, and industry practices from the latest publications, relasted to your system or area will be assessed against.

b.   Through a detailed review of your systems and documentation, our reviewers assess the quality of your operation.

c.   The assessment will define the gaps or non-compliance issues and rate the finding against a point numbering system.

d.   The numbering systems will layout the level and area of non-compliance. (documentation, training, quality reviews, engineering and so on.)

e.   The outcome can be presented in a graphical format acknowledging problem areas.

f.   The items identified during the assessment will be follow-up with meetings and tracking of punch list items assuring that all findings are corrected.

3.   Types of Assessments / Audits

Quality Assurance Programs

-    Review of Change Control Management

-    Document Control Systems

-    Batch Record Review

Regulatory Compliance Assessments may include:

-    Evaluation of Quality Management System

-    Internal cGXP Audits

-    CGMP Compliance Evaluation

-    Review of the Validation Studies, and Documentation

-    Review of Investigation Reports

-    Resolution of Compliance and Quality Problems

-    Compliance Review of Facilities and Equipment

-    Review of Employee Training Programs/ Vendor Compliance

-    Software Assessment Against IEEE Standards

-    Computer Systems Validation

-    System Security, Vendor Audits

-    SOP, Programs and Corporate Policies

-    Analytical Laboratories Audit

V.    Validation

Our consulting standards have been utilized throughout the industry and are kept up-to-date with the FDA's and EMEA's latest Regulations and Guidelines, along with supporting agencies publications and Industry practices.

The Compliance Group, Inc. can support you in the many areas of validation:

-    Equipment and Utility Validation

-    Cleaning Validation

-    Computerized Systems Validation

-    Sterilization / Sanitization Validation

-    Process Validation

A proper pharmaceutical validation starts with the introduction of the Validation Life Cycle described in our Validation Master Plan…

1.   Validation Master Plan

Our Standard Validation Master Plans are structured, to clearly define proper Validation / Qualification path for GXP relevant areas in a clear format; to identify the background, cleanroom monitoring and validation, computer systems validation, cleaning validation, process validation, boundaries and critical systems; minimum requirements to assure a validated process; to define the specific test functions and acceptance criteria; and to define support systems and procedures to assure continued compliance throughout the systems validation lifecycle.

Many Validation Master Plans have been developed through our compliance consulting efforts and are available to apply to your process:

a.    Validation Master Plan - Facility, Equipment, Process

b.    Computerized Systems Validation (CSV) Master Plans

c.    Cleaning Validation Master Plan

2.   Validation Procedures

Our consulting services utilizes a standard package of procedures includes basic procedures to assure compliance during the qualification. These procedures are:

a.    Validation Overview,

b.    Good Documentation Practices,

c.    Protocol Review and Approvals,

d.    Preparing Qualification Protocols,

e.    Executing Qualification Protocols,

f.    Comments and Deviations,

g.    Preparing Summary Reports.

Through our consulting services and compliance consultants, we have developed magnitudes of procedures for all types of processes. Also see our Programs Guidelines, and Quality Systems Section.

VI. Computer Systems Validation

We have on staff IT professional in computer systems design, computer systems validation and 21 CFR Part 11 regulations with regulatory compliance and project management experience to assist you with equipment, packaging lines, PLS's, SCADA's, BAS, LIMS, MRP, and SAP systems. Some areas in which we can provide support are listed below:

1.   Computer Systems Validation

a.    Validation Master Plan

b.    Vendor Audits

c.    User Requirements Specification (URS)

d.    Functional Requirements Spec. (FRS)

e.    Technical Design Specification (TDS)

f.     Requirements Tracability Matrix (RTM)

g.    Source Code Review

h.    System Startup & Commissioning

i.     Installation Qualification

j.     Operational Qualification

k.     System Summary Report

l.     Periodic Review

2.   Procedures

a.    Corporate CSV Guidelines

b.    Project Change Control

c.    Periodic Review of Computerized Systems

3.   CSV Assessments, Audits, and Inventory

a.    CSV Assessment and Compliance Audit

b.    Inventory of CSV Systems, Equipment, & Components

c.    Part 11 Assessments and Part 11 Systems Inventory

d.    Compliance Assessments - Security, System Data Storage, Backup and Recovery

4.   Qualification & Developing Software Test Methods

a.    Computerized Systems

-    System Test Plan

-    Installation and Operational Qualification

-    I/O Testing, Loop Testing, Proportional Integral Derivative (PID)

-    Functional Testing

-    Backup, Data Storage,Alarms, and Point Verification

-    Screen Graphics,Data and Calculations Verifications

-    System Remediation & Deviation Resolutions

-    Review of Test Data and Final Reports

b.    Software

-    Software Qualification Plan

-    Application Software Qualification

-    Code Reviews, Modular System Integration Testing

-    User Interface Testing

-    Password and Security Verification

VII.   Programs Guidelines and Quality Systems

Supporting the Validation Process is important and needs a refined quality system and programs that may include a series of procedures to coordinate a process. Our consulting services, compliance consultants and project managers are specialized in many areas and many programs that have been developed for implementation and some examples are listed below:

1.    Engineering, Commissioning, Facility Maintenance

a.    Engineering Project Management System

b.    Engineering Documentation Requirements System

c.    Commissioning and Documentation Requirements System

d.    Preventative Maintenance Program-Facility and Equipment

e.    Maintaining Spare Parts Inventory

f.    Calibration Program-Equipment and Instruments

g.    Work Order Program

2.    Validation and GXP Areas

a.    Equipment, Facility, Process, Cleaning, and Methods

b.    Protocol Templates

c.    Environmental Monitoring System

d.    Revalidation Program

e.    Change Control Program

f.     Cleaning Validation

g.    Laboratory Equipment Qualification System

h.    Analytical Methods Development

i.     Analytical Methods Validation

j.     Environmental Controls and Facility Cleaning Guideline

k.    Aseptic Processing Guidelines

Copyright © 2003 The Compliance Group, Inc. All Rights Reserved