Vapi

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ABOUT AUTHORS
Suleman S. khoja * ¹, Dr. L J. Patel ², Sohil S. Khoja ³, Karim R. Panjwani ³, Jagdish Ray^3
1 PhD. Research Scholar, Ganpat University, Mehesana, Gujarat, India
² Faculty of Pharmacy, Ganpat University, Mehesana, Gujarat, India
³ Resource person, Pharmaceutical Quality Assurance, Audit and Compliance, Vapi, Gujarat, India

ABSTRACT
Good documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with GMP requirements. Documentation requirements of maintaining complete, accurate, truthful and verifiable data in all cGXP documents that are needed to be maintained as per regulatory requirements and various Governmental regulations, laws, rules and statutes/acts. Documentation may exist in a variety of forms, including paper-based, electronic or photographic media. Ensure that the Document should be free from error and during any point if error identify then rectify with proper reason for correcting including sign and date. A system should be in place to indicate special observations and any changes to critical data. GMP Document must have predefined retention period and document must be stored in secure and easy to retrieve or easily available as and when required. Batch Processing and Packaging Instruction must be in place and Contemporaneous entry provision must be available. Instruction and procedure for using equipment; instrument must be clear and specific.  Specification with authorization should be available for analysis of Raw Material and Packing Material, Intermediate and Bulk Product, Finished Product.

Glenmark Pharmaceuticals Ltd is one of India's leading research-driven, global, integrated pharmaceutical company. Glenmark has Offices in over 40 Countries. It has 17 manufacturing facilities in 5 countries, with over 12.000 employees from over 60 nationalities. 5 world-class research and development center, the group is dedicated to improving people live. We have following vacancies at our API Manufacturing location at Ankleshwar, Gujarat.

Alembic Limited, with an established presence in the Indian pharma  industry has a proud, historical track record going back one hundred years. With a turnover in excess of Rs1000 crores today, Alembic Limited is one of India’s leading integrated pharmaceutical companies. We continue to enjoy leadership positions in antibiotics, anti-infective, anti-cough and also have significant worldwide presence in specialty therapeutic areas such as cardiology, neurology, diabetology, etc. We have also plans for expansion in Ophthalmic etc.

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UMEDICA is a part of the Amoli Group of Companies, manufacturing and exporting a wide range of formulations viz; Injectable, Tablets, Capsules, Suspensions, Dry Syrups, etc. UMEDICA offers a diverse product portfolio comprising of antibiotics, non-steroidal anti-inflammatory (NSAIDs), analgesics, antifungal, antiviral, anti-malarial, anti-tuberculosis agents, antihistaminic, psychotropic, anti-hypertensive, lipid lowering agents, drugs for sexual dysfunction, multivitamins etc.

Aculife Healthcare Private Limited is one of world’s largest Infusion & Injectable Company, having its global operation spread across 70 countries including JV Company in Brazil & wholly owned subsidiary in Mexico. 8 Manufacturing Plants Backed up by state of the art. Aculife Research Centre & 4000 plus Employee base in India & abroad. To keep up with the scale of operations & requirements of regulated and semi regulated markets, Aculife is enhancing its focus on healthcare initiatives across the global Markets.

Mylan is one of the world's leading generic and speciality pharmaceutical company, providing products in around, 150 countries, through our global workforce of more than 18,000 passionate leaders. If you resonate with our audacious ambition to provide the world's 7 billion population with access to high quality medicine, with state of art og finished dosage form manufacturing facility at Aurangabad. These facilities are compliant of USFDA, WHO, MHRA & MCC.

Alembic Limited, with an established presence in the Indian pharma  industry has a proud, historical track record going back one hundred years. With a turnover in excess of Rs1000 crores today, Alembic Limited is one of India’s leading integrated pharmaceutical companies. We continue to enjoy leadership positions in antibiotics, anti-infective, anti-cough and also have significant worldwide presence in specialty therapeutic areas such as cardiology, neurology, diabetology, etc. We have also plans for expansion in Ophthalmic etc.

Macleods has its presence in over 30 countries with more than 300 registrations.The export range of Macleods are manufactured in a unit that has QSM approval from WHO-Geneva, and certifications from various International Regulatory Authorities like - USFDA, MCC, UKMHRA, MOH – Belarus, INVIMA – Colombia, National Drugs Authority - Uganda, Food and Drugs Board - Ghana, MCAZ – Zimbabwe, Pharmacy and Poisons Board Kenya, Pharmacy Board Tanzania etc.