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Introduction and Overview of

Quality Control
1
QUALITY CONTROL FOR REGULATED
ENVIRONMENTS
UNIVERSITY OF HOUSTON

Introduction
2

Biopharmaceutical quality control serves several purposes

It confirms the identity and quality of starting and raw materials,


assures that no major deviations are taking place during processing,
and finally assures the identity and quality of the drug substance and
drug product

Data collected during development, scale up and

manufacture comprises a valuable repository of


information, which can be used for trouble-shooting,
comparability and equivalence studies
Control should be exerted on all levels and should
constitute an integrated part of the total quality assurance.

Specifications
3

The manufacturer must ensure the quality and safety

of the drug substance by a series of test procedures


with established acceptance criteria to which the
drug substance must conform
An important part of the total control strategy is to
provide analytical batch data and compare these with
the specified acceptance criteria

Quality control levels


4

Quality control is exerted on several levels:

Raw materials
In process control
Intermediary compounds
Drug substance and drug product

Analytical methods
5

Analytical methods should be available for

assessment of biological activity, immunological


activity, purity, and quantity

Furthermore, methods for characterization of the drug


substance should be available.

Some methods are generic of nature and method

descriptions can be found in the United States or


European Pharmacopoeia
Other methods are specific and needs to be
developed in parallel with the process

Analytical Methods
6

All analytical procedures should be validated before

used in late clinical trials, but it accepted to use


qualified procedures in early development and for
early clinical trials

The level of qualification may vary and close contact to


regulatory authorities on this matter is recommended.

Almost identical methods may be used for in process

control and analysis of drug substance and drug


product.

Minor deviations may occur due to the nature of the sample

Reference materials
7

The development and maintenance of an analytical

method totally depends on internal or external reference


standards
Internal reference materials are produced initially
during process development using material from the
first batches produced according to the protocol
Later, when material is manufactured in the pilot plant,
reference material will be taken from this bulk
Enough quantities of reference material should be
stored making later comparability and equivalence
studies possible

Quality Assurance / Quality Control


Whats the Difference?
8

Quality Assurance
Ensure the manufacturing and laboratory operations are
compliant with cGMP practices
Approve and reject raw materials and product batches
Quality Control
Testing of raw materials, in-process materials and final
products
Developing, validating, and performing assays
Providing analytical support for validation and
environmental monitoring programs

Quality Organization
9
Safe

Quality Assurance is

responsible for the


appropriate deployment
of the GMPs and the
overarching Quality
System
GMPs are responsible
for the establishment of
a Quality Control unit
All, together, help to
ensure safe and
effective products

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