Welcome to the third and final part of the 3 part exclusive unwrapping of the observations reported from the US FDA’s inspection of Lupin Pharmaceutical’s facilities. If you have directly jumped to this page, we would request you to read through the earlier posts before you proceed ahead. Though this is not mandatory, a good read is a good read only if read from front to last and not from the last to the front.
Part 3 – Covering the FDA’s inspection of the Mandideep facility. This facility has 2 separate units. The Unit 1 or the API manufacture unit and Unit 2 or the finished drug manufacturer unit (sterile and non-sterile) unit. Additionally both these units have separate approvals for packing operations as well. These facilities have not been through a re-inspection process yet and hence we cover only the initial inspection below.
Do note that we have covered the observations from the Mandideep facility based on the IIFL and Lupin reports. However, the below analysis would only confirm those as we now have complete access to the form 483.
Mandideep facility – Unit 1 or the API manufacture unit
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Initial Inspection Observation 1
What we understand:
The inspection mentions that the rejected lots of intermediaries used for the production of sterile API without being included as part of the standard manufacturing process. The APIs that used these rejected intermediates were made into the finished drugs and commercially distributed from 2012 to 2015.
It is unclear whether the issue noted is:
- Rejected intermediates were used or
- SOP did not mention that rejected intermediates can be used
However, the company did confirm that this relates to this observation relates to 1 sterile product which did not impact the end product.
Initial Inspection Observation 2
What we understand:
This relates to the contact time required for disinfectants to take effect when used in the cleaning of the operator’s hands during aseptic processing (remember the life buoy campaign). The company confirmed that this relates to user’s contact time with the hand sanitizer and that they were able to demonstrate to US FDA that the contact time (30 seconds) required for sanitization is being followed adequately.
Mandideep facility – Unit 2 or the finished drug manufacturer unit
Initial Inspection Observation 1
What we understand:
This basically means that the capsule checkweigher can only check the weight of the capsule of a single weight. The inspection revealed that the capsule checkweigher is deficient if multiple capsules of different weights are weighted. The company claims to demonstrate that the checkweigher was qualified for other weights.
While we side with the company on this matter, the checkweigher would render useless if the so happens that multiple weight capsules of multiple sizes are mixed together erroneously and weighted at the same time.
The inspection report also mentions that the maximum speed (Maximum speed is nothing but the maximum number of products that can be checkweighed in 1 minute. The actual speed changes with the product size and required accuracy) observed did not match the maximum speed as was required by the validation protocol. Though not much information is available as to what the variance was, this can happen if there is randomness in the feeding of the products. Hence the checkweigher speed may require some margin or it may be necessary to place a fixed interval feeder.
Initial Inspection Observation 2
What we understand:
This is similar to the issue that the FDA has noticed in the company’s Goa manufacturing facility. Not only does it relate to the absence of procedures related to the cleaning and maintenance of equipment but also with the cleaning protocol of the operators’ hand during the aseptic processing.
The company in their response to the IIFL report only confirmed the second part of the observation while the company failed to even acknowledge the first part of the observation related to the absence of procedures related to the cleaning and maintenance of equipment. You can refer the previous explanations to understand this better.
With this we end our 3 series posts. You can read the first part of the series here or the second part of the series here
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We hope you have a good learning experience from these posts. We welcome your feedback and comments.
Disclosure: Capital Mind had earlier recommended Lupin as part of a 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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