How current good manufacturing practices (CGMP) can assist in the - - PowerPoint PPT Presentation

▶
how current good manufacturing practices cgmp can assist
SMART_READER_LITE
LIVE PREVIEW

How current good manufacturing practices (CGMP) can assist in the - - PowerPoint PPT Presentation

Dec 30, 2022 131 likes •258 views

How current good manufacturing practices (CGMP) can assist in the availabiilty of low cost pharmaceutical products of assured quality Humberto Zardo Pharmaceutical Operations Improvement Irvine, CA USA Roundtable on Generic RH

slide-1
SLIDE 1

Roundtable on Generic RH Supply Beijing, 7 November 2006

  • H. Zardo

1

How current good manufacturing practices (CGMP) can assist in the availabiilty of “low cost pharmaceutical products of assured quality”

Humberto Zardo Pharmaceutical Operations Improvement Irvine, CA – USA

slide-2
SLIDE 2

Roundtable on Generic RH Supply Beijing, 7 November 2006

  • H. Zardo

2

Affordability and Quality

Affordability - The extent to which pharmaceutical products are available to the people who need them at a price they can pay. Quality assurance - Is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the decisions made with the

  • bjective of ensuring that pharmaceutical products

are of the quality required for their intended use.

Ref.: WHO-TRS 937, 40th Report, 2006

slide-3
SLIDE 3

Roundtable on Generic RH Supply Beijing, 7 November 2006

  • H. Zardo

3

Matters that individually or collectively influence the quality of a product

  • 1. Starting materials

i. Active pharmaceutical ingredient (API) ii. Excipients

  • iii. Primary container / closure

Findings:

  • Lack of assurance from the real manufacturer
  • Myth and reality of cost impact
  • Sampling and testing practices

Ref.: Market Development Approaches Working Group Subgroup on non-OECD generic manufacturers

slide-4
SLIDE 4

Roundtable on Generic RH Supply Beijing, 7 November 2006

  • H. Zardo

4

Matters that individually or collectively influence the quality of a product

  • 2. Premises (WHO TRS 908, annex 4, 12.24)

i. Dedicated and self-contained ii. Allows for the sequence of the operations

  • iii. Allows for the requisite cleanliness levels

Findings:

  • Different interpretations of “self-contained”
  • Lack of unidirectional flow
  • Construction and materials difficult to clean

Ref.: Market Development Approaches Working Group Subgroup on non-OECD generic manufacturers

slide-5
SLIDE 5

Roundtable on Generic RH Supply Beijing, 7 November 2006

  • H. Zardo

5

Matters that individually or collectively influence the quality of a product

  • 3. HVAC (WHO TRS 902, 908, and 937)

i. ISO Class 8 (100,000) “at rest” for solids; & Class 5 (100) for injectables ii. Design and location of supply air diffuser or UDAF and return air

  • iii. Pressure gradient &

Number of air changes per hour

Findings:

  • Limited number of plants in full compliance
  • Some willing to comply

(WHO TRS 937 and ISO 14644)

  • Others facing major challenges for compliance

Ref.: Market Development Approaches Working Group Subgroup on non-OECD generic manufacturers

slide-6
SLIDE 6

Roundtable on Generic RH Supply Beijing, 7 November 2006

  • H. Zardo

6

Matters that individually or collectively influence the quality of a product

  • 4. Water for pharmaceutical use

i. Drinking Water ii. Purified Water

  • iii. Water for injection

Findings:

  • Limited number of plants in full compliance
  • Improper design and lack of qualification
  • Happy to see WHO TRS 929, annex 3

and TRS 937

Ref.: Market Development Approaches Working Group Subgroup on non-OECD generic manufacturers

slide-7
SLIDE 7

Roundtable on Generic RH Supply Beijing, 7 November 2006

  • H. Zardo

7

Matters that individually or collectively influence the quality of a product

  • 5. Equipment

i. Design and construction ii. Capacity

  • iii. Maintenance

Findings:

  • Some companies have well balanced

process flow and equipment

  • Others disregard critical aspects of the process

Ref.: Market Development Approaches Working Group Subgroup on non-OECD generic manufacturers

slide-8
SLIDE 8

Roundtable on Generic RH Supply Beijing, 7 November 2006

  • H. Zardo

8

Matters that individually or collectively influence the quality of a product

  • 6. Methods, Specifications & Sampling

i. Above and beyond compendia ii. Limits (Alert and Action)

  • iii. Rational for sampling

Findings:

  • Comfortable with old compendia and tables
  • Happy to see WHO TRS 929
  • Willing to apply process capability (Cpk & Ppk)

Ref.: Market Development Approaches Working Group Subgroup on non-OECD generic manufacturers

slide-9
SLIDE 9

Roundtable on Generic RH Supply Beijing, 7 November 2006

  • H. Zardo

9

Matters that individually or collectively influence the quality of a product

  • 7. Qualification / Validation

i. Design ii. Installation

  • iii. Operational
  • iv. Performance

v. System Validation

Findings:

  • Happy to see WHO TRS 937

Ref.: Market Development Approaches Working Group Subgroup on non-OECD generic manufacturers

slide-10
SLIDE 10

Roundtable on Generic RH Supply Beijing, 7 November 2006

  • H. Zardo

10

Matters that individually or collectively influence the quality of a product

  • 8. Training

i. Program ii. Instructors

  • iii. Records
  • iv. Follow-up and re-evaluation

Findings:

  • Proactive companies are far better than those

that react to external audits and complaints

Ref.: Market Development Approaches Working Group Subgroup on non-OECD generic manufacturers

slide-11
SLIDE 11

Roundtable on Generic RH Supply Beijing, 7 November 2006

  • H. Zardo

11

How can low cost and assured quality be compatible?

  • Managers believe that quality is essential
  • Suppliers become partners for continuous

process and quality improvement

  • Evolve from pass-fail to quality indicators
  • Eliminate reworks & rejections
  • Select, train, empower, and retain

qualified people