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Turn - Key QMS Implementation and Remediation Compliance Solution

New Start-up? Short on Resources?
Let TKQMS Fulfil your Quality Management System Requirements

info@auditing.com
Tel: 001-856-596-2333

Templated ready procedures developed and ready for implementation for Pharmaceutical,Medical Device, Dietary Supplements, and Cosmetics

Manufacturing/Processing, Laboratories, Storage, Distribution, Packaging and Compounding
- - Corporate Quality Policy and Quality Mission Statements
- - Quality Manuals - Specific for your Industry
- - Validation Master Plan - Corporate Validation Methodology
- - Facility Qualification Plans and Facility Site Master Plans and Files
- - Corporate Risk Statements
 
Not all may apply, based upon applicability
(F - With Associated Forms)
- QMS Procedures
  - - - Standard Operating Procedures - SOP/WI (F)
  - - - Requesting, Writing and Challenging Procedures (F)
  - - - Risk Management (F)
  - - - Corrective and Preventative Actions (CAPA) (F)
  - - - Non-Conformance (F)
  - - - Change Control (F)
  - - - Deviations (F)
  - - - Complaints Management (F)
  - - - Recalls and Recall Challenge (F)
  - - - Quality Assurance Procedures (other)
  - - - Internal Audit (F)
  - - - External Audit (F)
  - - - Agency Audit
  - - - Customer Audit
  - - - Traceability (F)
  - - - Good Documentation Practice (GDocP) Standards
  - - - Document Management and Document Control (F)
  - - - Document Management Archive and Disposition (F)
  - - - Form Management (F)
  - - - Logbook Control and Quality Review
  - - - Out of Specification (OOS) (F)
  - - - Contractors
  - - - Regulatory Affairs
  - - - Product Safety
  - - - Reporting to Regulatory Agencies
  - - - Audit Reports
  - - - Annual Product Review
  - - - Annual and Preschedule Quality Meetings (Review) (F)
  - - - Out of Trending / Out of Tolerance (OOT) (F)
  - - - Rework and Reprocessing (F)
  - - - Managing Visitors (F)
  - - - Pharmacy Operations
  - - - Compounding
  - - - Disaster Recovery and Business Continuity (F)
  - - - Signature Logs
  - - - Review of Quality Documents (Batch/Assembly Records)
  - - - Review of Quality Critical Documents
  - - - Review of Contracts and Scope of Work Agreements
  - - - Vendor Qualifications (F)
  - - - HACCP Management
  - - - Research and Development
  - - - Pilot Plant Scalability
  - - - Process Improvement
 
- Human Resources
  - - - Training and Development
  - - - Hiring and Releasing
  - - - CV Management
  - - - Roles, Responsibilities and Job Descriptions
  - - - Employment
  - - - GMP Training Curriculum with Curriculum
  - - - GLP Training Curriculum with Curriculum
  - - - GCP Training Curriculum with Curriculum
  - - - Employee Safety
  - - - Background Checks and Drug Testing
  - - - Regulation of Food, Drink and Smoking
  - - - New Employee Orientation
 
- Warehouse, Receiving and Shipping
  - - - Receiving - Materials
  - - - Quarantine - Incoming and Finished Products
  - - - Rejected Materials
  - - - Sampling - Area Management
  - - - Inventory Control - Cycle Counting and Reconciliation
  - - - Label Management and Label Control
  - - - Retains - Area and Inventory Management
  - - - Reserves - Area and Inventory Management
  - - - Experimental - Area and Inventory Management
  - - - Returns - Area and Inventory Management
  - - - FIFO - First In - First Out Management
  - - - Waste - Area and Inventory Management
  - - - Cleaning - Area
  - - - Shipping - Area Management
  - - - Controlled Environments and Area Management
  - - - Sterilization
  - - - Serialization
 
- Facilities
  - - - Asset Management
  - - - Maintenance and Preventive Maintenance Management
  - - - Work Order Management
  - - - Pest Control
  - - - Metrology and Calibration Management
  - - - Engineering and Engineering Change Management
  - - - Drawings, Schematics and Flow Diagram Management
  - - - Contractors and Consultants
  - - - Environmental, Safety and Health
  - - - Temperature / Humidity Management
  - - - Building Monitoring/Management Systems
  - - - Filter Management
  - - - Balancing Load Management
  - - - Housekeeping and Janitorial
  - - - Plant/Facility Security Management
  - - - Control Substance Management
  - - - Biological Product Management (BLS 1,2&3)
  - - - Emergency Safety Evaluation
  - - - Handling of Hazardous Materials
  - - - Handling of Flammable Materials
  - - - Drain Cleaning and Sanitization
  - - - Cleaning and Maintaining Air Handling Equipment and Ducting
  - - - Gowning and De-gowning Procedures
  - - - Use of Approved Cleaning Chemicals
  - - - Redundant Systems (Generators, Grids and UPS systems)
  - - - Compressed Air Systems (General Use and Process)
  - - - Compressed Gas Systems
  - - - Vacuum Systems
 
- Quality Control and Laboratories
  - - - Sampling Incoming and Finished Products and Materials Receipt
  - - - Sampling, Testing & Approval or Rejection of Components
  - - - Sampling, Testing & Approval or Rejection of Active and Inactive ingredients
  - - - In-Process Control Points
  - - - Batch or Assembly Record Review and Verification
  - - - Sample and Test Article Management
  - - - Balances and Scales
  - - - Laboratory Information Management System
  - - - Electronic Notebook System
  - - - Reagent Management
  - - - Column Management
  - - - Test Samples
  - - - Qualification and Validation
  - - - Contractors
  - - - Stabilities and Stability Management
  - - - Water Systems Testing, Potable, Purified and WFI Systems
  - - - Microbiology and Sterility Testing
  - - - Reporting and Record Management
  - - - Verification Process
  - - - Disposal of Process Waste and Effluent
  - - - Release of Finished Materials
  - - - Quality Agreements
 
- Validation/Qualification
  - - - Process Validation
  - - - Equipment Validation
  - - - Software and Computer Systems/Hardware Validation
  - - - Cleaning Validation
  - - - Facility Qualifications
  - - - Method and Analytical Process Validation
 
- IT and Electronic Systems
  - - - Backup and Recovery
  - - - Disaster Recovery and Business Continuity
  - - - Backup and Recovery Challenging Process
  - - - Upgrade and Downgrade
  - - - Change Control
  - - - Configuration Management
  - - - Software / Systems Development Life Cycle 
  - - - Development of Software/Systems User Requirements Specifications (URS)
  - - - Development of Software/Systems Functional Requirement Specifications (FRS)
  - - - Software Use Policies and Internet Usage
  - - - Software Risk Assessment
  - - - Hardware Risk Assessment
  - - - Network Access Policies
  - - - New Hardware Installation
  - - - New Software Installation
  - - - Hardware Maintenance
  - - - Software Maintenance - OEM and Internal
  - - - Computer Systems Hardware Testing and Validation - Writing Installation Qualifications, Operational Qualifications, and Performance Qualifications
  - - - Computer Systems Software Testing and Validation - Writing Installation Qualifications, Operational Qualifications, and Performance Qualifications
  - - - 21 CFR Part 11 Electronic Systems / EU Annex 11 Computer Systems
  - - - Virus Protection, Log reviews and Definitions updating processes
  - - - UPS and Redundant Power Supply
  - - - Imaging of computer systems (Clients and Servers)
  - - - Data Base Administrator (DBA) Procedures
  - - - Ghosting and/or Mirroring Processes
  - - - MS Excel Qualification
  - - - Off Site Storage
  - - - Tape Management, Chain of Custody and Degaussing Procedure
  - - - Internal Systems Audit
  - - - Vendor Qualifications, Hardware, Software, Consultants and Contractors,  ASPs/ISPs/IaaS/SaaS
  - - - Administrative Rights
  - - - Database Administrative Activities
  - - - Physical Security
  - - - Computer Room Management and Alarming Systems
  - - - Computer Room Environmental Systems and Alarming Systems
  - - - Help Desk Management
  - - - Drawing, Schematics, Flow Diagrams and other Quality Critical Documents
  - - - Good Programming Practices
  - - - Code Management
  - - - Test Platforms
  - - - Qualification and Validation
 
- Manufacturing and Processing
  - - - Device History Files (DHF)
  - - - Device Master Records (DMR)
  - - - Batch Record Management (BRM)
  - - - Batch Master Records (BMR)
  - - - Dispensing of Materials
  - - - Cleaning of Equipment (Cleaning Qualification)
  - - - Use of Status Labels (Equipment and Areas)
  - - - Packaging Procedures
  - - - Line Clearance Procedures
  - - - Staging Procedures (Materials, Components and Labels)
  - - - Use of Approved Lubricants, Oils and Cleaning Agents
 
- Clinical
  - - - Serious Adverse Event Reporting (Clinical)
  - - - Investigator Site Audit and Monitoring (Clinical)
  - - - Good Clinical Practice Training (Clinical)
  - - - Clinical Supply Management (Clinical)
  - - - Clinical Trial Initiation
  - - - Clinical Trial Closure
  - - - Set up and Management of a Clinical Trial Database
  - - - Informed Consent in Clinical Trials
  - - - Financial Disclosure of Investigators
  - - - Control of Clinical Trial Drug Supplies (CTM)
  - - - Investigator Site Selection
  - - - Labelling of Medical Products for Clinical Trials
  - - - Collection and Archiving of Clinical Trial Documentation
  - - - Remote Archiving of Documentation
  - - - Registration-Inclusion of Subjects in Clinical Trials
  - - - Ethics Committees
  - - - Clinical Trial Protocol
  - - - Clinical Trial Protocol Amendments
  - - - Case Report Forms for Clinical Trail
  - - - Final Study Report of a Clinical Trial
  - - - Trial Master Files (TMFs)
  - - - Verification of Source Documents
  - - - Planning and Preparation of Annual Safety Reports
  - - - Safety Committee and Safety Reports
  - - - Management of SAEs, AEs, and ARs.
  - - - Preparation of IND Annual Reports
  - - - Product Recalls
  - - - Pharmacy Management
  - - - Clinical Trial Record Management
  - - - Clinical Audits and Audit Reports
  - - - Statistical and Bio-Statistical Operations
  - - - Clinical Programming Standards
  - - - Clinical Trials Randomization
  - - - Personnel Training - Clinical
  - - - Clinical Research Project Confidentiality Agreement
  - - - Investigators Brochure
  - - - Clinical Data Flow
  - - - Clinical Trial Monitoring
  - - - Development of Clinical Trial Database
  - - - Database Audits
  - - - Database Locks and Unlocking Procedure
 
 

Turn-Key QMS - Provides extensive turn-key QMS Implementation Services supporting Regulated and Non-Regulated industry.

All of the tools that you require to implement a fully functional FDA/EMA QMS approved program in a fraction of the time it would cost to hire full time support.

GMP/QMS Templates to satisfy all regulated industry (based upon applicability). Experienced SMEs qualified for all industries to assist where needed.


GMP - QMS Requirements;

If products, or services, or any action, in whole or in part, which may impact either directly or indirectly, is distributed, adhered, affixed, consumed, or used by a Consumer or Patient, either by Use, Ingestion, Injection, Inhalation, and/or Permeation, they must follow GMPs, or…

If a product is manufactured, or services rendered which greatly benefits the safety, health or welfare of a consumer or patient, directly, and/or indirectly, or…

If a Product or Data which may influence, form a decision for, or create an adverse reactionary event to the health, safety, welfare of a Consumer or Patient, directly or indirectly;

You must comply to the GMPs!

So, what is a Product? What are Services? What are Data? What is direct and/or Indirect impact?

Your applicability to the Federal Regulations is based upon the Product, Service or Data that you provide. And the question is, what is your applicability, directly and/or indirectly?
And this is the hardest concept to understand.

 
Would you like a formal quote for a Turn-Key QMS Package?
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US FDA - WHO - EMeA - GMP - GLP - GCP

Pharmaceutical - Medical Device - Clinical - Laboratory - Part 11 - Food - Dietary Supplement

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a GMP, GLP, GCP, Quality Systems, - Part 11 & QSR Part 820 audit?
 

Get an independent assessment of your quality and regulatory readiness today! 


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