Category: Pharma Best Practices

What are the guidance documents that govern MDDs?(Microbial Data Deviation Investigations)

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Regulatory and Guidance Documents •2006 FDA Guidance for Industry – Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production. •ICH Q6A •ICH Q7A •USP 31 <1117> Best Microbiological Practice •Addressed in PMF Newsletter (Sutton and Settineri) http://www.microbiologyforum.org/PMFNews/PMFNews.12.11.0611.pdf (Sutton) http://www.microbiologyforum.org/PMFNews/PMFNews.13.06.0706.pdf (Settineri) •Addressed in PDA Draft Technical Report Points to Consider When Investigating Microbiological Data Deviations Read more about What are the guidance documents that govern MDDs?(Microbial Data Deviation Investigations)[…]

Pre Approval Inspection and things to look for

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Following are the key things you should look for pre approval inspection. Deviations, OOS, product failures Investigations and CAPA’s Label control QA oversight Management oversight Drug Safety and Pharmacovigilance projects Process, shipping cleaning method Vendor and contractor qualification and oversight Deviations gives the indication of break down in one or all of the following:Equipment, processes, SOP’s, Read more about Pre Approval Inspection and things to look for[…]

Dos and Don’t during and after FDA inspections

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This is a collection of facts from different experts and not the whole thing, there might be other dos and don’ts other than these applicable as per particular situation. Dos Present business card Be prepared Be organized Be calm Be professional Be confident Have Scribe present at all times during the interview Leave as soon Read more about Dos and Don’t during and after FDA inspections[…]

Pointers Inspectors look for during FDA inspection – For CAPA (QSIT)

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see that corrective action taken to correct existing product nonconformity or quality problems and Prevent recurrence of the problem The corrective action should Include explanations for how the firm will meet the requirements for all elements of the CAPA subsystem Gain working knowledge of the firm’s CAPA procedure before beginning evaluation of this subsystem Have Read more about Pointers Inspectors look for during FDA inspection – For CAPA (QSIT)[…]

FDA Compliance General (Med device, Pharma, Biotech)

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Q – How can you define a varying load in sterilant? Answer -Usually the load selection is done by reviewing all the products in the sterile family and making a judgement. It may be helpful to get a bunch of product samples on a table in the conference room, and have a meeting with the Read more about FDA Compliance General (Med device, Pharma, Biotech)[…]

Supplier Qualification Regulations

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There are various regulations formulated by different agencies highlight as a whole or part the supplier qualification guidelines. few are below. ISO 13485 Clause 4.6.2: Assessment of Sub-contractors–ISO 13485:2003 – Clause 7.4.1 mimics previous clause; standard adds explicit reference to “outsourced process” (4.1) – Clause 7.4.1 – The type and extent of control applied to Read more about Supplier Qualification Regulations[…]

Dos and Don’ts of responding to Unsoliciated offlabel requests

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Be specific, truthful, unbiased and scientific Avoid Public responses Keep private response specific to the question Make sure the persons responding on behalf of you are medical or scientific personnel Make sure sales and marketing personnel are not involved at all even in training and awareness Makes sure you are keeping record of all the Read more about Dos and Don’ts of responding to Unsoliciated offlabel requests[…]

FDA warning Indian drug manufacturing units – Is it a retaliation to court ruling against Novartis

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One after other drug manufacturing units of India getting warning letters or getting banned to manufacture licenses getting cancelled. Is this a systematic fight back (to the set back of patent disputes in favor of local generic manufacturers)  by big pharma by their arm twisting techniques or is it real the plants are not following procedures. Today Hospira’s manufacturing unit in Read more about FDA warning Indian drug manufacturing units – Is it a retaliation to court ruling against Novartis[…]