Reviewing Pharmaceutical Manufacturing Records
Pharmaceutical products, pharmaceutical industry, pharmaceutical contract manufacturing
First of all what does the pharmaceutical industry do, it has the main function
of developing and producing licensed drugs which are mainly used for medication
purposes for humans or animals. The industry includes manufacturing, extracting
and packaging processes. Manufacturing refers to mainly producing the active
ingredient for the drug then making it suitable for administration. It is
made suitable for various dosages required for different people. It is subjected
to a variety of laws and regulations such as patenting, testing and marketing
of drugs. Breaking any of these laws, the company can be subjected to legal
case and cancellation of licenses.
To review the drugs from the company their batch records need to be
checked. The Activities from the pharmaceutical manufacturing process
are archived in to a document called batch record. This is the main written
proof of what the product consists of. There are certain laws and criteria
to be followed during making the drug products and they should comply
to these laws, they can differ from country to country so make sure that
they follow all the regulations according to your country and are following
good manufacturing practices.
Drug manufacturers have to mainly follow ISO guidelines to ensure their
quality level to the highest. So you can cross check all their rules and
production practices with the International standards. Following such
guidelines they can easily ensure the safety of use of their product for
human or animal consumption.
Making the drug product is similar to the cooking process you have to
get the right ingredients or components for the same and drug products
are made. But in this case high level of accuracy and precision id required
as drug products have to be very accurate and are sometimes in very very
small quantities still of very high quality. So it is mainly an automated
process and under controlled environments only. It is completely controlled
by manufacturing process. Still every detail of the process is recorded
by the respective operator. Even the slightest details though how ignorable
they are must be recorded in the batch record. The batch record contains
all the information on the drugs such as weight, readings of temperature
during and after production, equipments used, etc. All these factors are
verified to see if they follow the regulations and laws.
You can compare all the processes undergone during the process in the
batch record with the Industry recommended processes in the ISO or FDA,
according to your local laws whichever is applicable. Regulations require
that a quality assurance person be present to check whether the quality
of the product is up to par and is according standards. The main goal
should be to verify the GMP compliance and to see that the entire final
product has all the components required. After the quality assurance person
has properly verified that batch results when compared to the lab printed
report according to which the product is to be made and also all the archived
documentations are up to date. Then only after all the checks are made
to satisfaction, the company is allowed to send the final product for
packaging.
From here the product is sent to various distribution centres and is marketed
then.
