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Content

Quality Auditing

Quality Auditing


AUDITING ENGINEERING AND MAINTENANCE

The process of converting starting materials into a finished product invariably requires plant and equipment. In pharmaceutical manufacture, engineering is involved in four broad areas;

  • the design of premises
  • the maintenance of premises
  • the design of equipment & utilities
  • the maintenance of equipment & utilities

    • Includes:
  • The Place of Engineering & Maintenance
  • Facility Design
  • Engineering & Facility Maintenance
  • Engineering & Equipment Design
  • Maintenance
    •

    DVD / 2008 / 32 minutes

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    AUDITING PACKAGING

    The physical packaging and labeling of pharmaceuticals is not dissimilar to packaging and labeling many other products, with pharmaceuticals however, the consequences of getting it wrong are severe. It isn't just that taking the wrong drug won't improve the patient's condition, it could, in some cases, worsen the condition or even kill the patient.

    The same goes for taking the wrong dosage - an overdose of some drugs can be lethal. So, control over packaging and labeling is somethingthat GMP takes very seriously.

  • Pharmaceutical packing
  • Assessing the risks
  • Doing the audit
  • Auditing the packaging supplier
    •

    DVD / 2008 / 15 minutes

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    AUDITING TOPICALS

    The manufacture of creams and ointments are not expected to be sterile but there must be very thorough microbiological controls throughout their manufacture, which is a critical point of focus in auditing the facilities where they are being manufactured.

  • Making topical products
  • Starting the audit
  • Topicals manufacture
  • Filling & packaging
    •

    DVD / 2008 / 19 minutes

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    AUDITING TABLETING

    Medication such as tablets and capsules are innocuous looking objects that may contain a multitude of ingredients for a multitude of purposes, from relieving headaches to more serious remedial actions.

    Mainstream product they may be, but auditing them for content, methods and quality, is a core auditing skill.

  • Auditing tableting & solids
  • Contamination control
  • Auditing each stage of production
  • Review
    •

    DVD / 2007 / 17 minutes

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    AUDITING THE DISPENSARY

    This is where the starting materials are measured out in the correct amounts in preparation for manufacturing into finished products.

    Dispensing is an activity that can give rise to many potential mistakes, which is what GMP sets out to prevent and what we have to bear in mind as we audit the area.

  • The Go Wrong Things of Dispensing
  • Separate, Clean & Decent
  • Dispensary Procedures
    •

    DVD / 2007 / 13 minutes

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    AUDITING THE WAREHOUSE

    The warehouse is the physical interface between the GMP regulated pharmaceutical manufacturing facility and the rest of the world. An audit must start somewhere and it is logical to follow the process flow. The starting point of virtually all process flows is the warehouse.

  • An audit must start somewhere
  • Goods reception area
  • Sampling area
  • The building & housekeeping
  • Organization
  • Special requirements
    •

    DVD / 2007 / 16 minutes

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    AUDITING CLEANING

    'A self-evident truth is that if you don't get your cleaning right you're in for trouble. So, when auditing vendors, contractors or internally for the quality of cleaning, a lot rests on the auditor's observations...'

  • The risk
  • Auditing the cleaning
  • Auditing validation of cleaning
    •

    DVD / 17 minutes

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    AUDITING LABORATORIES

    omeone, somewhere, has to prove that what is being made is correct, that it was made with the right ingredients, that it was made without any contamination and in the right environment - the Quality Control laboratory.

    Checking that laboratories do it right, and have the right quality system in place is what your laboratory audit is all about. This program is a framework to guide you through the process of auditing a laboratory.

  • Laboratory infrastructure and principles
  • Data and records
  • Analytical chemistry labs
  • Microbiology labs
  • Packaging materials testing laboratory
    •

    DVD / 24 minutes

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    AUDITING QUALITY SYSTEMS

    Today, we recognize that product quality is as much a matter of our approach or attitude of mind. We depend on quality systems, which require that at each stage of the process, products are manufactured to a pre-determined range of quality criteria. This is commonly described as having quality "built-in" from concept to completion.

    Quality auditing is one of those criteria and therefore auditing the quality system itself is among the highest of high priorities.

  • Quality & Quality Systems
  • FDA Guidance on Quality Systems
  • The Quality Policy Document
  • Auditing the System
    •

    DVD / 15 minutes

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    AUDITING STERILE PRODUCTION AREAS

    Without question, the most critical areas in any plant are where sterile products are made, often under aseptic conditions.

    These are areas which the auditor must address in considerable detail, starting with the environment and how it is monitored. Obviously operating practices and how they are observed are critical, as are personnel matters and equipment and its cleaning. All of which must be satisfied during the audit.

  • Access to Aseptic Manufacturing Areas
  • General Overview of the Facility
  • Air Filtration and Pressure Differentials
  • Requirements for Areas within Aseptic Manufacturing
  • Equipment for Aseptic Manufacture
  • Monitoring of Aseptic Areas
  • Validation
  • Personnel
  • Filtration
  • Testing
    •

    DVD / 25 minutes

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    AUDITING TRAINING

    Many companies realize that a well trained labor force is not just a cost but also an investment in the now and future wellbeing of the organisation. If the organization is regulated and required to comply with GMP guidelines then training will be a central part of management philosophy.

  • Training Policy
  • Training Needs Analysis
  • Training Inventory Analysis
  • The Training Plan
  • Supervision, Assessment and Performance
    •

    DVD / 10 minutes

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    INTRODUCTION TO GMP & QUALITY AUDITING

    Disc 1 "Introduction to GMP & Quality Auditing" DVD The core multimedia training module presented in a six-part Video-based documentary style program:

  • What do we mean by quality?
  • An Audit
  • Quality Systems, Standards and Codes of Practice
  • Pre-audit preparation
  • The Audit Process
  • The Audit Report

    • Disc 2 The training module comes complete with the MVI QuestionMaster multiple choice knowledge assessment quiz. Shipped with preset questions and fully editable up to 200 questions in five competency levels.

    Disc 3 "The MVI Guide to GMP & Quality Auditing" The guide provides the written manual on which the multi-media programs are based.

    Disc 4 "Virtual GMP Plant Audit"

    Disc 5 "Virtual Sterile Production Plant Audit"

    5 DVDs / 50 minutes

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