Amit B Prajapati has over 12 years of experience in quality assurance roles in the pharmaceutical industry. He currently works as an Executive Quality Assurance at Sun Pharma, where he manages IPQA and ensures regulatory compliance. Previously, he worked at Novartis Vaccines in quality assurance roles, managing change control, deviations, audits, and regulatory inspections. He has a degree in biochemistry and medical laboratory technology.
Experienced, results-oriented professional with broad experience in pharmaceutical quality processes and problem solving. Expertise in reviewing complaints, SOPs, Batch Records, and other documentation for accuracy and completeness. Skilled in preparing for internal or external audits and correcting deficiencies. Demonstrated ability to bring new facilities into FDA compliance. Proficient in SAP and Trackwise. Areas of expertise:
PQMS | Batch Record Review | Controlled Substances | Document Control
FDA Regulations | Metrics Reporting | GMP / GLP, OSHA
Ian brings 16 years of experience in the Biotech/Pharmaceutical Industry in Quality Assurance and Quality Control. He has extensive knowledge of all of the applicable regulatory requirements.
My last projects as an independent contractor were with SHIRE, LONZA and NOVARTIS. I conducted Product Investigations from Inoculations of Media to Manufacturing projects which included from line clearance issues to inclusions of foreign material. Also, Inspection of all product packaging to determine a non-negative product impact.
Experienced, results-oriented professional with broad experience in pharmaceutical quality processes and problem solving. Expertise in reviewing complaints, SOPs, Batch Records, and other documentation for accuracy and completeness. Skilled in preparing for internal or external audits and correcting deficiencies. Demonstrated ability to bring new facilities into FDA compliance. Proficient in SAP and Trackwise. Areas of expertise:
PQMS | Batch Record Review | Controlled Substances | Document Control
FDA Regulations | Metrics Reporting | GMP / GLP, OSHA
Ian brings 16 years of experience in the Biotech/Pharmaceutical Industry in Quality Assurance and Quality Control. He has extensive knowledge of all of the applicable regulatory requirements.
My last projects as an independent contractor were with SHIRE, LONZA and NOVARTIS. I conducted Product Investigations from Inoculations of Media to Manufacturing projects which included from line clearance issues to inclusions of foreign material. Also, Inspection of all product packaging to determine a non-negative product impact.
NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORI0ES (NABL)SAM VIVEK
NABL specifies the general requirements for the competence to carry out tests and calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.
Benefits of Accreditation:
Potential increase in business due to enhanced customer confidence and satisfaction.
Savings in terms of time and money due to reduction or elimination of the need for re-testing .
Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent.
Duties & Responsibilities of Quality Assurance Managerssagarusms14
Quality assurance managers play an important role in business by ensuring that products meet certain thresholds of acceptableness. They plan direct or coordinate quality assurance programs and formulate quality control policies. They also work to enhance an organization's efficiency and profitableness by reducing waste. If you're conscientious, inquisitive and committed to excellence, you'll realize it gratifying to work in this quality compliance occupation.
• Competent professional with 10+ years of experience in executing
In-process quality assurance by monitoring complete pharma
manufacturing process in order to comply with the specifications
• Over all responsible for IPQA Activities (both manufacturing and
packing area of solid orals, Nasal spray and Liquid dosage forms)
• Ensure the compliance of quality events like deviation
management, temporary change control, permanent change control, CAPA, Market complaints.etc.
• Active participation in root cause investigation and proposal of CAPA for deviation, market complaint and batch failure.
• Effectiveness check of implemented CAPA in shop floor.
• Calibration Management –ensure calibration of all IPQA instruments as per schedule.
• Skilled in preparation and review of Annual Product Quality Review (APQRs)
• Review of SOPs/work instructions-Gap identification and compliance of the same.
• Conducting in-house cGMP audits to ensure compliance and sound functioning of the process.
• Provide training regarding any changes to existing system and introduction of any new system.
• Knowledge on OOS, OOT, Site Master File.
• Hands-on experience in preparation of Process validations, cleaning validation, hold time study protocols and BMR and BPR preparation.
• Making Sure that products are manufactured according to legal and Customer requirements.
• Diligently Verifies document Completion and Compliance.
Unit 2 organization and personnel and permisies himanshuhimanshu kamboj
pharmaceutical quality assurance
b pharma 6th sem
Personnel objectives
Personnel qualifications
Personnel responsibilities
Key personnel
Responsibilities of the head of the production department
Responsibilities of the head of quality control department
Training
Personnel hygiene
Premises
Layout of pharmaceutical industry
Areas of premises
Environmental control in sterile areas
Equipment and raw materials
Stages of equipment
Cleaning and maintenance
Raw materials
Steps involved in purchase procedure
Maintenance of stores
Storage conditions
NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORI0ES (NABL)SAM VIVEK
NABL specifies the general requirements for the competence to carry out tests and calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.
Benefits of Accreditation:
Potential increase in business due to enhanced customer confidence and satisfaction.
Savings in terms of time and money due to reduction or elimination of the need for re-testing .
Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent.
Duties & Responsibilities of Quality Assurance Managerssagarusms14
Quality assurance managers play an important role in business by ensuring that products meet certain thresholds of acceptableness. They plan direct or coordinate quality assurance programs and formulate quality control policies. They also work to enhance an organization's efficiency and profitableness by reducing waste. If you're conscientious, inquisitive and committed to excellence, you'll realize it gratifying to work in this quality compliance occupation.
• Competent professional with 10+ years of experience in executing
In-process quality assurance by monitoring complete pharma
manufacturing process in order to comply with the specifications
• Over all responsible for IPQA Activities (both manufacturing and
packing area of solid orals, Nasal spray and Liquid dosage forms)
• Ensure the compliance of quality events like deviation
management, temporary change control, permanent change control, CAPA, Market complaints.etc.
• Active participation in root cause investigation and proposal of CAPA for deviation, market complaint and batch failure.
• Effectiveness check of implemented CAPA in shop floor.
• Calibration Management –ensure calibration of all IPQA instruments as per schedule.
• Skilled in preparation and review of Annual Product Quality Review (APQRs)
• Review of SOPs/work instructions-Gap identification and compliance of the same.
• Conducting in-house cGMP audits to ensure compliance and sound functioning of the process.
• Provide training regarding any changes to existing system and introduction of any new system.
• Knowledge on OOS, OOT, Site Master File.
• Hands-on experience in preparation of Process validations, cleaning validation, hold time study protocols and BMR and BPR preparation.
• Making Sure that products are manufactured according to legal and Customer requirements.
• Diligently Verifies document Completion and Compliance.
Unit 2 organization and personnel and permisies himanshuhimanshu kamboj
pharmaceutical quality assurance
b pharma 6th sem
Personnel objectives
Personnel qualifications
Personnel responsibilities
Key personnel
Responsibilities of the head of the production department
Responsibilities of the head of quality control department
Training
Personnel hygiene
Premises
Layout of pharmaceutical industry
Areas of premises
Environmental control in sterile areas
Equipment and raw materials
Stages of equipment
Cleaning and maintenance
Raw materials
Steps involved in purchase procedure
Maintenance of stores
Storage conditions
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
In a welcome move, the Pharmacy Council of India has recently re-structured the syllabus of the
Bachelor of Pharmacy course. In the effort to make the content more relevant to the practice of
pharmacy in its current form, we now find new, important subjects introduced, and Pharmaceutical
Quality Assurance is one of them.
1. Amit B Prajapati
302, Purav Flat, Opp. LBS School, Karelibaug, Vadodara, Pin-390023
Mobile No.: +91 94263 13006 Email: abprajapati11@yahoo.co.in
PROFESSIONAL PROFILE
A self-managed and result-oriented Quality professional in pharmaceutical industry with more than
twelve years of experience in Audit management and Compliance, Change control, Deviation
management, Product Technical Complaints, Corrective and Preventive Actions, Validation and
Area qualifications, Risk Assessments, Good Documentation Practices, Vaccine Quality Control
and Remediation projects.
Experienced in facing inspections from regulatory authorities like USFDA, MHRA, WHO Geneva, MCC
South Africa, SFDA China, Gulf Coordination Council, KFDA Korea, TFDA Tanzania and DOH Taiwan.
A resourceful and result-oriented team player with integrity, professionalism and personal presence that
earn respect and inspire cooperation. Possess excellent communication, interpersonal and decision-
making skills together with a positive approach to problem solving.
SELECTED ACCOMPLISHMENTS
• Successfully managed FDA inspection for IPQA functionary with zero observations at Sun
Pharmaceuticals at Halol.
• Successfully lead and implemented Novartis remediation strategy (M& Q Plan) developed against
FDA warning letter.
• Certified Lead investigator and Trainer for investigations of deviations and complaints.
• Authored and developed systems for handling of returned product (first in division) and product
recall.
• Implemented quality modules as per global and corporate quality management systems.
• Lead and managed internal audits and vendor audits.
EMPLOYMENT EXPERIENCE
SUN PHARMA, Halol , Gujarat (USFDA and MHRA approved facility) Feb 2013 - Present
Executive Quality Assurance
• Ensuring IPQA (QA on the shop floor) is effective and fully integrated with manufacturing
operations confirming to Quality and regulatory Compliance for sterile formulation operations.
• Participated in design meetings, coordinated site activities for qualification of new or remediated
facility. Responsible for QA activities related to commissioning, qualification and validation.
• Ensuring Batch production records are reviewed and approved with resolution of issues occurring
in the shop floor.
• Ensure APR’s for all bulk drug substances and drug products are completed annually.
• Review and approve validation documents, facility/process risk assessments, critical deviations
and change controls.
• Review and approval of starting materials and manufactured batches in ERP system (Bill of
Material, Deviated work order, Work order receipt, Consumption order, Adjustment issue etc.)
including final batch.
• Participate and lead investigation meetings with representation from manufacturing, Quality
control and engineering. Ensure prioritizing and timely resolution of investigations impacting
product dispositions, track progress towards closure of investigations including product impact
and CAPA. Track and trend investigations and provide update to plant management (in Quality
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2. Council meets) on the status of open and closed investigations. Responsible for issuance of field
alert report and escalation of critical incidents.
• Certified Lead investigator and trainer for Deviations and Complaint investigations. Actively
participate in teams focused to implement quality systems.
• Review and monitor aseptic practices during production and media fill runs for sterile formulations
provide mentoring and coaching of aseptic operators. Design and execute media fill validation
studies for sterile filling operations including supervision of media fill vial inspection process,
batch record review and approval of media fill report.
• Design and develop Environmental monitoring regimes for cleanrooms based on risk
assessments and monitoring of successful implementation through monitoring and trending.
• Actively organize, manage and participate in external regulatory inspections (FDA, MHRA, and
KFDA). Organize prep sessions and mock inspections in preparation of regulatory inspections.
Identify significant compliance issues and work towards resolution including preparing defendable
responses. Participate in post inspectional response teams and formulate response(s) within
established timelines by senior management.
• Lead and support internal audits, supplier audits and FAT of critical equipment’s.
Novartis Vaccines , Ankleshwar, Gujarat (WHO Prequalified facility) Jun 2005 - Jan 2013
Executive Quality Assurance
• Ensured change control and deviations systems are in compliance with global procedures and
current regulations.
• Functioned as Quality Systems coordinator responsible for review of change controls, deviations
and CAPA’s. Lead change control review boards and Deviation review boards for review and
resolution of change proposals and deviation investigations. Participated as site lead in global
change control committees for changes impacting multiple sites.
• Ensured change controls are implemented in timely manner and deviations investigations are
complete and closed within stipulated timelines. Managed KPI’s against site and global targets.
Drawn Trends reports for deviations and presented to site management and global management
in Site Quality Council meets and Senior management review meetings (global).
• Performed gap assessments against Novartis Quality Module requirements and aligned
procedure and practices to bring systems into compliance. Authored new procedures against
Quality Module requirements.
• Reviewed and approved site SOP’s, starting material specifications, packaging material
specifications, validation protocols, gap assessments, and risk assessments.
• Managed site stability programme by developing stability study protocols, monitoring, execution,
preparation of stability reports and aligning procedures with ICH regulations and global
procedures.
• Functioned as QA responsible for primary manufacturing of vaccines and supporting in the
designing, review and approval of batch manufacturing records.
• Participated in external regulatory inspections (WHO, SFDA, MOH Iran, MOH Mexico, GCC).
Organize prep sessions and mock inspections in preparation of regulatory inspections. Identify
significant compliance issues and work towards resolution including preparing defendable
responses. Participate in post inspectional response teams and formulate response(s) within
established timelines by senior management.
• Support internal audit management team by leading internal audits and supplier audits.
• Responsible for alignment of global KPI’s and reporting of site KPI’s to global functions and site
management.
• Participated in global task forces and focus groups for KPI’s, Deviations, Change controls and
Stability
• Functioned as site Project Management Officer for Manufacturing and Quality plan (M&Q plan
(Management & Quality plan was introduced as a part a commitment to USFDA against warning
letter) to implement global strategy at site. Coordinate with global project manager, Site
management for alignment and reporting of activities.
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3. o Lead teams for gap assessments against all 483 observations issued to Novartis and
remediation of gaps identified through implementation and monitoring
o Performed review of complaints to align with global requirements
o Performed FMEA for product mix with global expert, created report and developed
remediation strategy.
o Participated in strategy and review meetings with global senior management.
• Executed risk assessment during qualification of new area for Environmental monitoring regime.
Novartis Vaccines , Ankleshwar, Gujarat (WHO Prequalified facility) Dec 2002 - Jun 2005
Officer Quality Control
• Performed animal testing (Potency, Pyrogen, Toxicity and general safety test) of the finished
products, intermediate product and packaging materials on mice, guinea pig and Rabbit
• Supervised the animal house facility in compliance with cGMP and CPSCEA regulations.
• Assisted with scheduled environmental monitoring of production areas in addition to monitoring
utility systems (WFI, DM and Clean Steam).
• Compile and evaluated environmental and water testing data and performed trend analysis
• Supervise and train technical personnel within the QC for animal testing activities.
• Prepare and revise standard operating procedures and other GMP related documentation as
needed.
EDUCATION/PROFESSIONAL DEVELOPMENT
Diploma in Medical Laboratory Technology, INDIAN MEDICAL ASSOCIATION, Vadodara, India 2001
Master of Science (Bio Chemistry), SARDAR PATEL UNIVERSITY, V.V.Nagar, Gujarat 2000
Bachelor of Science, SARDAR PATEL UNIVERSITY, V.V.Nagar, Gujarat 1998
PROFESSIONAL TRAININGS
• Attended 12 Day cGMP Foundation course by Lachmann Consultants
• Trained and Certified on Investigations and Train the trainer program by Lachmann Consultants
REFERENCES
• Available upon request
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