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Quality by design

 QbD is systematic approach to development and begins with predefined objective and emphasises product, process understanding and process control, based on sound science and quality risk management.  QbD enhance the assurance of product safety and effective drug supply to customer  QbD also offer promise to significantly improves manufacturing quality performance  QbD having below steps- 1. Define Target product profile (use, safety and efficacy of the product) 2. Define Target quality product profile - used by the formulator and process engineer as quantitative surrogate for the aspects of clinical safety during development. Gather relevant prior knowledge about drug substance, critical raw materials and process operation in to knowledge space. Use risk assessment to prioritise for knowledge gaps for further investigation. 3. Design formulation and identify Critical quality attributes/ Critical material attributes of final product, which required to be controlled to...
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Salary discussion

Hehe thanks for asking me that. You would also know the state of inflation today. And how hard its to catch up with that. I really have big hopes with this change and looking forward for something which can make some significant impact in my household and lifestyle. and I definitely want to see good numbers in the offer letter.
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Interview

1. Have you gone through job role ? And is there anything you wanted to ask? 2. There is two different positions with different requirements and responsibilities, what you will prefer? 3. You have diverse profile, what is the reason behind? Have you worked as whatever you got opportunity - you grasped are you have changed your interest frequently? 4. What are the components in investigation? 5. Tell me examples of deviations and investigation? 6. Guideline for propylene glycol  7. Why hold time study is required  8. Overtalk 9. Sorry  10. Please 
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Audit and compliance

Audit readiness Reference https://www.fdanews.com/ext/resources/files/The_Food_And_Drug_Letter/2013/Inspection-Readiness-ExecSeries.pdf https://ispe.org/initiatives/regulatory-resources/gmp/audit-checklist# Before start of audit we need to review past audits and note indication of possible problem areas and items, if any ensure that were identified for corrective actions in a previous audit. If not aware about facility learn what products being produced and how it is organised with personal and function. To have systematic audit checklist to be prepared and alongwith notebook it needs to be utilised (notebook required to make detailed entries while audit and checklist is to guide auditor). Atleast three production batches to be selected For thorough analysis to include- a) Traceability of all components or materials used in that batch. b) Documentations of raw materials or components, inprocess and finished goods testing for subject product batches. c) Warehousing and distribution reco...
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Change Management System

US Market (Supplement): Post approval drug manufacturing supplement for NDAs/ ANDA submitted to FDA for Major or Moderate manufacturing change. Major change - If a manufacturing change is considered to be major, an applicant must submit and receive FDA approval of a prior-approval supplement (PAS) before the drug product made with the change is distributed. Moderate change- If a manufacturing change is considered to be moderate, an applicant must submit a supplement at least 30 days before the drug product is distributed (a CBE-30 supplement) or, in some cases, submit a supplement at the time of distribution (a CBE-0 supplement).  “CBE” means “changes-being-effected”. Post manufacturing supplement - 1. CBE 0 (Change being effected before 00 days): 2. CBE 30 (Change being effected before 30 days): 3. PAS (Prior approval supplement): EUROPE Market (Variation): A variation to the terms of a marketing authorization is an amendment to the contents of the docume...
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Critical quality events-QP

Critical quality events-QP EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use - Annex 16: Certification by a Qualified Person and Batch Release Quality Event: The event occurred during manufacturing / analysis of batch / lot or event occurred during the batch / lot is in the distribution system or as a market feedback which is likely to have potential impact on finished product Qualified Person (QP): QP is the person responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the marketing authorization (MA) and with Good Manufacturing Practice (GMP) Periodic Events Notification- Quality events summary report shall be prepared on quarterly basis 1.     Incidents- Incidents which have a systemic effect: · Any validation / qualificat...
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Steam sterilization

Steam In Place - Steam In Place vs Sterilize In Place- Steam in place term used to describe in situ sterilization using steam. Sterilize in place term used to describe in situ sterilization using various types of gaseous or liquid sterilizing agents including steam. Terminal sterilization = Steam under pressure - A probability of no more than one no-Sterile unit in a million (10-6) is readily achievable. Aseptic - A controlled process or condition in which the level of microbial contamination is reduced to the degree that microorganisms can be excluded from a product during processing.
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