Академический Документы
Профессиональный Документы
Культура Документы
In-process control
Introduction
Sources of Quality variation:
The diversity of drugs and dosage forms produced, the size and
complexity of the operation and varying processes and
equipments employed differ from company to company.
The manufacture of pharmaceutical products frequently involves
a series of successive processing operations and each of these
operations can be expected to have some influence upon the
quality of the finished product.
The risk of error increases as the number of materials involved in
a formulation becomes greater, the process becomes more
complex and the operation becomes larger.
Excipients control:
Excipients are components of the finished dosage form other
than the therapeutic ingredient.
Although they are inert, they may influence the quality of a
product owing to interaction with the drug substance affecting the
physical properties of the dosage form or influencing the
production process.
To prevent such effects:
Excipients should be examined carefully and critically for compliance with
established standards.
They must be supplied in clean and properly sealed containers.
They should be inspected prior to laboratory testing.
Labeling should be correct.
The material should be packaged in the correct container.
No obvious damage of the container in transit.
Lot number should be stated.
In-process checks
Monitoring cleaning
When a batch of a certain drugs has been made, all equipment that
has been used must be cleaned.
When the next pharmaceutical to be made on that line is going to be
different, this cleaning must be particularly through to prevent
contamination. In this instance, after cleaning the QC staff take
swabs off each piece of equipment and test them to see if they can
detect the presence of the active previously used.
The results of all these tests are recorded on the batch records for
the pharmaceutical, as well as the name and batch number of the
pharmaceutical made immediately prior on the same production
line.
Raw material standardization is the only way for all the drug
manufactures to produce the drugs in same quality and to maintain
the uniformity.
Raw materials
1. Medicinal
Minerals
Herbs and animals etc.
Microbes, pathological products, healthy tissues, drugs
2. Non medicinal (vehicles)
Alcohol, lactose, sugar, white petroleum jelly, maize starch,
coconut oil, wax
Transfer
Store
Sampling
Identification
Analysed
Equipments
Inspected
Manufacture
Assessed and
control of microbial
contamination
Documented
Purity testing
Finished
products
Representative
samples analysed
Table 27-1 lists general tests, limits and other physical or chemical data for
raw materials related to identity, purity, strength and quality.
Table 27-2 presents the quality assurance monograph for acetaminophen,
USP, as an example of a specific raw material quality assurance monograph.