SHANKAR GUPTA

QMS Framework is responsible for defining the quality standards inlining with regulatory standards to ensure for consistent supply of quality medicine to the patients. Basically QMS framework design per ISO 9001:2015 standards and follow structured hierarchy - There will be three levels - Level 1- Strategic level - Policy, Manual and module - documents in this level can't be presented to HA inspections  Level 2 and Level 3- Operational level - documents in this level can be presented to HA inspections  Level 2- procedures, batch records, protocol etc Level 3- Record and reports Understanding and identifying “interested parties” is one of the foundational requirements of ISO 9001:2015, as outlined in Clause 4.2. Yet many organizations struggle with this task — not because it is difficult, but because it often feels vague or disconnected from day-to-day operations. In practice, identifying interested parties is understanding who affects or is affected by your quality management ...

 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...

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.

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 

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...

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...