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At Capital Mind, we bring you today another exclusive article in lines with our earlier production of the exclusive series on Lupin Pharmaceuticals form 483 for Aurangabad, Goa and Mandideep facilities. This time it is the form 483 for Glenmark Pharmaceuticals Pithampur facility.
Thanks to ET Now for bringing this information to the markets. The document is available only under FOIA, and by now making it available to our readers we hope to have brought more visibility with respect to the inspection.
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Glenmark Pharmaceuticals is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai, India. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenues. Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity).
Glenmark has several molecules in various stages of clinical development and is primarily focused in the areas of Inflammation [asthma/COPD, rheumatoid arthritis etc.] and Pain [neuropathic pain and inflammatory pain].
The company has a significant presence in branded generics markets across emerging economies including India. GPL along with its subsidiary has 16 manufacturing facilities in four countries and has six R&D centers. The Generics business of Glenmark services the requirements of the US and Western Europe markets. The API business sells its products in over 80 countries, including the US, various countries in the EU, South America and India.
Glenmark Pharmaceuticals (FEI – 3008565058) located at Plot No. 2, Phase-2, Pharma Zone SEZ Pithampur, Dhar, Madhya Pradesh 454775, India was inspected by the US FDA authorities from the 22-Feb-16 to 26-Feb-16. The plant does not manufacture API and rather is just a formulations unit.
It is surprising to see that the company failed to disclose any information about the inspection or on the receipt of form 483. The only confirmation the company provided was only when ET Now broke the news. Here is what the company said in a press release to the exchange
The Indore (Pithampur) plant was inspected by the USFDA in February, 2016 and we received three observations from them which are responded to in March, 2016. Subsequently we received two product approvals from this plant and we have no outstanding items with the USFDA regarding this plant.
Ob1: Production and Process Control
What does this mean? – This basically means that the tablets or capsules that the company manufactures are not of consistent weight and that there are no control procedures in place to check the reason for the weight variation.
Variation in particle size, particle shape, and/or bulk density can have an effect on the uniformity of dosage forms, specifically in case of direct compression or direct encapsulation.
Under the current GMP regulations, manufacturers must establish control procedures to monitor the output and validate the performance of manufacturing processes that may be responsible for causing variability in the characteristics of a drug product, including procedures on weigh variation and content uniformity (21 CFR 211.110(a)).
Ob2: Holding & Distribution
What does this mean? – As would every manufacturing firm have it, when the inventory data is entered in the warehouse inventory system, it is a mandatory requirement that the physical location (in the warehouses) of the products be recorded as well. This helps in easier identification and location of the products.
Glenmark does have a SAP system but looks like the firm has not been making use of the features or has been blatantly ignoring the requirement to fill in the details of the physical location of the products. This may not be a big issue as long as the physical documents can help back the SAP records. However this does raise the question as to the quality of inventory verification performed by the statutory and internal auditors as inventory verification is mandatory as per Company laws.
The first part is largely about tightening up access and validation of data, with adequate process control. This is again, not difficult to solve, though the degree to which the FDA might be different from what Glenmark has done, adding a layer of subjectivity to the FDA observation process.
What does this mean? – This is basically around the IT controls of the firm. Absence of Audit trial, Master Access to all, absence of SOD and usage of default settings for all users – a basic SOD issue that can be solved by having some rules built into the IT systems.
The form did mention that the software being used was Empower 3 software – a chromatography data software (CDS), makes it easier to run samples [Chromatography is a physical method of separation that distributes components to separate between two phases, one stationary (stationary phase), the other (the mobile phase) moving in a definite direction].
A change in software should help the firm. Another point of notice here is that the inspector has identified these only as system issues and has not been able to prove if any product manufactured by the firm were part of these violations which is a positive news for the firm.
We welcome your feedback and comments.
Disclosure: Capital Mind may have earlier recommended Glenmark as part of its momentum portfolios, but at the moment it is not a stock in any recommended portfolio. The authors at Capital Mind do not own it in their personal/family accounts, and the company does not own any position in the company’s stock. There is no business relationship between the companies mentioned and Capital Mind.
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