Essentials for Pharmaceuticals
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Essentials for Pharmaceutical Manufacturers

Purpose

Employees identify the essential elements of CGMP for beginning work in the pharmaceutical and biotech industries.

 

Objectives  

1.       State the historical development of CGMP regulations.

2.       Explain the role and function of standard operating procedures.

3.       Describe the personal role for contamination control.

4.       Identify the sources of contamination.

5.       List the common CGMP documentation practices.

6.       Explain material controls.

7.       State the common practices of production and process controls.

8.       Explain the importance of an adequate, appropriate, and sufficient building design.

9.       State the requirements of equipment design and construction.

10.    List the requirements for building, and equipment cleaning and maintenance.

11.    Explain the role of quality assurance.

12.    Explain the role of quality control.

   

About the Class  

1.       This class uses group-facilitated discussion, multi-media, problem solving activities and facilitated instruction to develop a solid understanding of CGMPs.

2.       The optional final exam is approximately 25 questions.

3.       Each student receives a student guide containing a representation of the program's slides and graphics with space provided for note taking.

4.       This class can accommodate up to 25 people.

5.       Duration: 16 hours.

 

To speak with the lead instructor for this class please call Allan Dewes at 415-948-5220 or submit the information request.
 
Course Topics

 

Past, Present, and Future

Definitions

Perspectives 1900-1962

Activity: Heard On The Street

From 1962 to the present

New issues and practices

Quality by Design

Design of Experiments

Design Space

Risk Assessment

21CFR211 -  Multi-media presentation

Consequences of non-compliance

 

People & Responsibilities

Personnel

Management

Organization and personnel

Training

Consultants and contractors

 

Standard Operating Procedures

QA responsibility

Uses of procedures

Writing, formatting and guidelines

Revisions and approval

Review frequency 

Activity: Writing Procedures

 

Contamination

Contamination Control - Multi-media presentation on CGMPs

Sources of contamination

Personal methods of contamination control

Penicillin controls

 

Personal hygiene

Rest rooms and hand washing

Clothing to be worn

Clean room activities

 

Documentation

Completion, checking, and correcting documentation

Error descriptions

Non-compliant practices

Fraud and falsification policy

Case Study: Able Pharmaceuticals

Activity: Real-time Documentation

Electronic records - Part 11

 

Materials

Supplier qualification

Material specifications, controls and identification

Sampling

Activity: Bead Sort

Receiving  materials

Non-conforming materials

Activity: Design a Product

 

Packaging and Labeling

Labels and labeling

Content of Labels

Material examination

Material controls

Branding

Label issuance

Packaging and labeling operations

Expiration dating

Specifications

Tamper-evident packaging

Case study: Tylenol

Activity: Design A Label

 

Production and Process Controls

Common Controls

Weighing of materials

Charge-in of active ingredients

Amount of active ingredient

Calculation of yield and values

Equipment identification

Statistical, random, or representative sampling

Finished product and in process testing

Time limitations on production

On line testing

Microbiological contamination control

Reprocessing

Documentation

Activity: Inspection Detection Subpart F

Buildings and Facilities

Design and construction features

Special construction considerations

Sufficient space defined

Product, equipment, material flow

Designated and defined spaces with examples

Rationale for environmental monitoring

Methods and parameters

Demonstrated control

Penicillin contamination

Lighting

Air systems

Water

Facility alarms

Waste

Housekeeping

Activity: Design A Facility

 

Equipment Design and Construction

Appropriate and suitable

Equipment selection

Blue prints of process

Control devices

Equipment construction materials

Lubricants

Filters design and specifications

HEPA Filters

Equipment use, cleaning and maintenance

Procedures and training

Levels of cleaning

Equipment cleaning logs

Work orders and repair orders

Log requirements and exceptions

Activity: Design A Dream Car

 

Calibration

Key elements

Measurement frequency

Timing, standards, and procedure

Logs for due dates

Consultants and outside firms

Out of calibration responsibilities

Out of service

Calibration documentation

 

Laboratory Purpose and Regulations

Subpart I - Laboratory controls

Establishes control mechanisms

Specifications, Sampling, and Testing

Choosing and using a sampling plan

Testing and release for distribution

Certificate of analysis

Analytical Results

When an OOS Occurs

Average laboratory results

Laboratory investigations

Stability Testing

Procedural requirements

Recent citations

Stability chamber

Determining expiration date

Accelerated stability

Reconstitution

Reserve Samples

Procedural requirements

Retention times

Method validation

Activity: Method Validation

 

The Role of QA

Definitions and regulations

Roles and direct reports

Suppliers and Contractors Qualification requirements

Outsourcing and checklist

Approvals or rejections

Incoming materials

Materials inspection and testing

Labeling specifications

Labeling control and use

Non-conforming materials  

Investigations

Investigations and reviews

Structure of an investigation

Investigation content

Types of investigations

QA Documentation

Product recall strategy

Depth of recall

Product recall classification

Activity: Design An Audit

 

Summary

Activity: CGMP Challenge

 

Call to learn about how we can customize this outline for any of your site's CGMP training needs. Standard outlines may change without notice. To speak with the lead instructor for this class please call Allan Dewes at 415.948.5220.

 

For a prompt reply to requests and questions:  415.948.5220 |  skillsplus@aol.com    |   Fax: 954.566.5225

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