Goods Manufacturing Practice

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GOODS MANUFACTURING PRACTICE
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Part 1
Food and Drug Administration (FDA) is a body responsible for offering protection to public
health through efficacy assurance, security and safety of human and drugs, cosmetics, medical
devices, food supply and products, biological products emitting radiation (FDA, 2018). On the
other hand, Sun Pharmaceuticals industries are focused with manufacturing and marketing of
pharmaceutical ingredients such as drugs. Moreover, in December 2015, FDA sent a warning
letter to Sun Pharmaceuticals Ltd on violating the FDA regulations on Good Manufacturing
Practices (GMP) as well as violation of record keeping and documentation laws (FDA, 2018).
Since FDA advocates for protection of public health, such regulations are critical to govern
manufacturers in various industries.
Furthermore, with regard to Deficiency 4, Sun Pharmaceuticals firm is considered to have failed
not only establish but also to offer documentation of accuracy, reproducibility, sensitivity and
specificity of test methods as per FDA regulations. Moreover, validation in analytical method
demonstrates the suitability of the testing procedure that is intended. Thus method validation
gives outcomes that are vital in assessing the quality, consistency and reliability of analytical
results. Thus the firm failed to evaluate accuracy on dissolution test method for (b) (4) tablets
during validation. On the other hand, from the FDA code of regulations based on the above
problems, the operating law in section 211.110 is based on production and process control.
Moreover, to ensure batch integrity and uniformity of drug products, there should be an
establishment of written procedures and then followed by tests, in-process control and
examination procedures. Consequently, such control procedures should be established for
monitoring the output as well as to also validate the performance of the manufacturing processes
which causes variability in in-process material as well as the drug product. In addition, such

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control procedures comprise of; disintegration time, bio burden testing, dissolution time as well
as rate, clarity, solutions pH and completeness.
On the other hand, Sun Pharmaceuticals failed in evaluating capacity of separating unidentified
late eluting peaks (b) (4) injection, (b) (4) ml or (b) (4) mg and HPLC (high performance liquid
chromatography). Additionally, the response of the firm in October 2014 stated that revised
method comprising (b) (4) chromatographic run time detection of late eluting peaks got approval
by FDA in 2014. However, from observations and scrutiny by FDA, it was noteworthy that there
was failure in documentation and the method was too inadequate and not promptly after the first
detection and investigation of impurities. In addition, the FDA and GMP were violated. Notably,
the GMP rules that are applicable to these problems include Laboratory Controls which involves
testing and release for redistribution. Thus such documentation and validation can be
accomplished in accordance with section 211.194 (a) (c).
Moreover, laboratory test would be utilized where any sampling and testing that is conducted has
to be descried in written steps which must include sampling method as well as various units
found in a batch. Furthermore, the instruments’ calibration, gauges, apparatus as well as
recording devices at right intervals in accord with conventional written program that has specific
directions, precision, schedules and limits of accuracy should be key to manufacturing.
Additionally, an appropriate number of batches of very drug need to be tested for determination
of correct expiry date thus a record of such information are maintained. Likewise, accelerated
studies in combination with fundamental stability information on various components, closure
system of a container and drug products are vital for supporting tentative dates of expiration.
In addition, during inspection of microbiology laboratory, it was observed that several sterile
gloves that were intended for use in the manufacturing of sterile products were immersed