The conditions under which drug substance and drug

products are manufactured, transported

and stored can influence their efficacy. Stability
studies in the pharmaceutical industry help to
estimate the impact of transportation and storage on
drug and medical device performance by
stressing materials under exaggerated environmental
conditions. Appropriate temperature,
humidity, and light conditions guarantee that drugs
are delivered to patients without loss of
therapeutic properties.
An active pharmaceutical ingredient is used in a finished
pharmaceutical product (FPP), intended to carry certain
pharmacological actions or otherwise have a direct effect
in the diagnosis, cure, treatment, mitigation or prevention
of various diseases, or in some cases in restoring,
correcting or modifying human physiological functions.
Sales of pharmaceutical ingredient are on the rise due to a
substantial increase in high-potency API (HPAPI) and
peptide API manufacturing. A new study conducted by
Persistence Market Research reveals that the US$ 151.9 Bn
global active pharmaceutical ingredient market will grow
to US$ 158.3 Bn by 2017 end, reflecting a Y-o-Y growth
rate of 4.2%. This market is estimated to further increase
to US$ 225.2 Bn, expanding at a CAGR of 4.5% over the
forecast period (2016 –2025)
The design of the stability studies for the FPP should be based on
knowledge of the behaviour
and properties of the API, information from stability studies on the
API and on experience gained from preformulation studies and
investigational FPPs. Data from stability studies should be
provided on at least three primary batches of the FPP. The
primary batches should be of the same formulation and
packaged in the same container closure systemas proposed
formarketing. The manufacturing process used for primary
batches should simulate that to be applied to production batches
and should provide product of the same quality and meeting the
same specification as that intended for marketing. Stability
studies should be performed on each individual strength, dosage
form and container type and size of the FPP unless bracketing or
matrixing is applied.
Stability testing of pharmaceutical products is addressed by the ICH (International Conference
on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human
Use) and the final guidance on stability testing has been adopted across Europe, Japan and the
United States.
Furthermore, the FDA states in 21 CFR part 203 section that manufacturers, authorized
distributors of drugs and their representatives shall store and handle all drug samples under
“conditions that will maintain their stability, integrity and effectiveness,” ensuring that the
drug samples are free of contamination, deterioration and adulteration.
Within stability test chambers, parameters such as temperature, humidity, differential
pressure, lighting, gas levels and other environmental conditions must be controlled,
monitored and documented. To reduce the risk of failed studies, a monitoring system designed
for both functionality and compliance is required. Functions should include data logging,
automated date file backup, monitoring and reporting via Internet access, connectivity options
including wireless, email, phone or text alarm notifications, multiple levels of data security,
which can include digital signatures, complete event and interaction history and audit trail.