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a PR3145 > LEC 2 > Flashcards

LEC 2 Flashcards

1
Q

Limitations of conventional product testing (3)

A
  1. Need representative sample
  2. Need to know what to test for and how to test them
  3. Need to validate testing processes (specific, accurate and reliable)
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2
Q

Limitations of batch sterility test

A

Means test for sterility between batches w/o GMP compliance etc

  1. Sterility test are not cheap (few hundreds)
  2. High probability of passing sterility test even if contamination is rather high
  3. Req storage space in the meantime and thus increase COP

Led to the development of Parametric Release of terminally sterilised LVPs

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3
Q

Quality Risk Management framework/steps (4)

A
  1. Risk identification
  2. Risk analysis
  3. Risk reduction
  4. Risk communication
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4
Q

Skills require by manufacturer and regulators

A
  1. Hard skills
    eg pharmaco theories
  2. Soft skills
    eg assertiveness, confidence, integrity and impartiability, tact and diplomacy
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5
Q

Definition of quality of medicines

A

Fitness for use for treating patients

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6
Q

Characteristics of quality of medicines

A
  1. Identity
  2. Potency
  3. Purity (cross-contamination & impurities)
  4. Stability (shelf-life)
  5. Homogeneity (consistency within batches and equivalency among batches)
  6. Critical quality attributes (CQA)
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7
Q

Sources of impurities (internal contamination)

A
  1. Process-related
    eg excess reagents & by-products
  2. Drug-related
    eg degraded API (after API formed)
3. Polymorphism (diff 3D crystalline structures)
eg carbamazepine (inactive and active)
  1. Stereoisomers (diff spatial structures)
    eg L and D isomers of dopamine and propranolol
  2. Container-closure system and labels

They are identifiable

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8
Q

Sources of cross-contaminations (external contamination)

A
  1. Personnel
  2. Premises
  3. Equipments

They are non-specific.
Preventable through manufacturer’s compliance to GMP and inspectors to carry out audit regularly

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9
Q

Types of stability testing for medicinal products (3)

A

Takes into account both environmental and product-related factors

  1. Real-time study
    - predict stability for 6months
  2. Accelerated study
    - predict stability beyond 6months
  3. Continual stability study
    - establish shelf life post marketing when stored, distributed and used under recommended temperature
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10
Q

Factors affecting stability of medicinal products (2)

A
  1. Environment
  2. Product-related
    eg dosage forms
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11
Q

What is process validation?

A

Process validation is the means of ensuring and providing documentary evidence that manufacturing processes are consistently producing a finished product of required quality standards

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12
Q

Major steps in process validation (6)

A
  1. Establish tablet quality specification
    eg hardness, friability
  2. Identify Critical Process
    eg milling, blending
  3. Design sampling plan
  4. Design testing plan
  5. Set acceptance criteria (LSL and USL)
  6. Perform statistical analysis (intra and inter batch)
    - Intrabatch: Process Capability (Cp)
    - Interbatch: Coefficient of Variance (CV)
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13
Q

Purpose of intra-batch analysis

A

To ensure consistency within batches

Cp >= 1.3 or outlier =< 63ppm

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14
Q

Purpose of inter-batch analysis

A

To ensure equivalency among batches

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15
Q

Conventional product testing & batch sterility testing

A

NOT THE SAME.
Conventional product testing is test for API.
Batch sterility testing is test for contamination in a product.

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16
Q

Parametric release

A
  • release of products based on key ‘parameters’ of a validated sterilisation process
    eg temp, RH, bioburden of pre-sterilised parental products

Developed from batch sterility test

Allows parametric release of terminally-sterilised large volume parentals (LVPs)

17
Q

Controls to reduce impurities (internal contaminants)

A
  1. QC testing of materials and finished product
  2. Assessment of impurity profile by HSA product reviewer
  3. GMP compliance
  4. Periodic GMP audits
18
Q

Controls to reduce cross-contamination

A
  1. Personel
    - wear PPE
  2. Premises
    - clean areas, pest control
  3. GMP compliance
  4. Periodic GMP audits
19
Q

How to show homogeneity of products produced?

A

Homogeneity is demonstrated through process validation

20
Q

Quality Risk Management (QRM) objective

A

To assess risks to product quality/patients and then manage these risks to an acceptable level

21
Q

Quality of medicinal products should be the concern and business of __ and __

A
  1. Manufacturers and distributors

2. Regulators

22
Q

What is contaminated products

A

Products that contains undesirable foreign matters
Can be from :
- impurities (intrinsic contamination)
eg in starting materials
- cross-contamination (extrinsic contamination)
eg during procuring, packing

23
Q

Why is there a need to control impurities? (2)

A

Therapeutic effects of medicinal product depends on :

  • API pharmacological properties
  • toxicity of impurities present

a PR3145 (14 decks)

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