Vapi

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ABOUT AUTHORS
Suleman S. khoja * ¹, Sohil S. khoja ¹, Karim R. Panjwani¹,
Jagdish Ray ¹ , Parthkumar H. chauhan ^2
1 Resource person in Pharmaceutical Quality Assurance,
Audit and Compliance, Vapi .
² Resource person in Quality Assurance,
Navsari
^*premukhoja@gmail.com

ABSTRACT:
It has been always International Regulatory concern on Role and Responsibility of Pharmaceutical Higher Management in  this review article we have taken some of the concern and how responsible  leadership should ensure the support and commitment of staff at all levels and sites within the organization to the Pharmaceutical Quality System ,management review , Quality committee and to make a platform for leadership engagement, awareness and decision making around quality and process performance. Implement new controls as per GMP Guidelines to check impact and management tool for identification and reduction of human Errors in pharmaceuticals Industry.

Alembic Pharmaceuticals Limited, with an established presence in the Indian pharma industry has a proud, historical track record going back over 100 years.

To realize our ambitious plans, we call upon dynamic, result oriented team members to join our API & Formulation manufacturing unit located at PANELAV, near Vadodara (Gujarat).

Post: Executive/Sr. Executive/Asst. Manager/ Dy. Manager/Manager

Torrent Pharma, the flagship company of Torrent Group, is ranked amongst the top pharma companies of India. It is a dominant player in the therapeutic areas of cardiovascular (CV) and central nervous system (CNS) and has achieved significant presence in gastro-intestinal, diabetology, anti-infective and pain management segments. Torrent Pharma has a strong international presence spanning over 70 countries across five continents with over 1200 product registrations. Today, Torrent Pharma, with its state of the art manufacturing and research facilities and a global presence, is all poised to carve a niche foritselfintheinternationalpharmaarena.lt is well set on an exciting growth phase in all directions.

Post : Manager / AM / Executive in QC & QA

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ABOUT AUHTORS
Suleman S. khoja * 1, Sohil S khoja 1,Parthkumar H chauhan 2,Farhad S Khoja 3 ,Shamim S Khoja3.
1) Resource person in Pharmaceutical Quality Assurance, Audit and Compliance, Vapi -396191.
2) Resource person in Quality Assurance, Navsari
3) Registered Pharmacist ,Gujarat State Pharmacy council, Vapi -396191
*premukhoja@gmail.com

ABSTRACT:
Data integrity is fundamental in a pharmaceutical quality system which ensures the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA), Arrangements shall be in place within an organisation with respect to people, systems and facilities that shall be  designed, operated and where appropriate adapted to support a working environment and  organisational culture that ensures data is complete consistent and accurate in all its forms, i.e. paper  and electronic record .When taken collectively these arrangements fulfil the concept of data governance. Regulatory bodies expect that data shall be reliable and accurate. CGMP regulations and guidance allow for flexible and risk-based strategies to detect and prevent data integrity issues. Industry should implement meaningful and effective strategies to manage their data integrity risks based upon their process understanding and knowledge management of technologies and best business models. In recent year Regulatory observation has increasingly observed GMP violations involving data integrity risks during CGMP inspections. This is troublesome because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, Regulatory is concern with ability to protect the public health.

Consistent growth and sustainability is a multidimensional aspiration for all at Macleods, we remained focused on providing quality and affordable medicines to billions of ailing patients across geographies and bridging the gap of unmet needs of medical fraternity through continuous innovation. Our basic business philosophy, by its very nature, serves a social responsibility hence we have a far better reason than profits alone to drive our performance.

Post : Officers/Sr.Officers

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ABOUT AUHTORS
Suleman S khoja*¹,Sohil S khoja¹, Farhad S Khoja²,Shamim S Khoja², Narmin A Pirani^2
1 Resource person in Pharmaceutical Quality Assurance and Facility Audit,
Vapi, Gujarat, India.
² Registered Pharmacist, Gujarat State Pharmacy Council, Gujarat, India
*premukhoja@gmail.com

ABSTRACT
A quality agreement is a comprehensive written agreement between parties involved in the contract manufacturing of drugs that defines and establishes each party’s manufacturing activities in terms of how each will comply with CGMP. Quality agreements may be reviewed during inspections. A quality agreement describes the owner’s and the contract facility’s roles and manufacturing activities under CGMP. The quality agreement should explain how the contractor will report manufacturing deviations to the owner, as well as how deviations will be investigated, documented, and resolved in compliance with CGMP. Quality agreements should state that manufacturing services provided by contract facilities (including laboratories) will comply with CGMP. The most critical pieces are quality and change control, as described in the following sections. Manufacturing Activities Change Control Associated With Manufacturing Activities

Medisol Lifescience Pvt. Ltd (MLPL) situated 165 km from Mumbai, near Vapi and located at Vill. Aklara. MLPL is a small scale factory of manufacturing pharmaceutical aerosols. Medisol Lifescience Pvt. Ltd (MLPL) is engaged in manufacturing of antiasthamatic Inhaler products for the treatment of asthmatic patients. We believe in serve to good and quality products to the society.

Asian Aerosol OAN Pvt. Ltd. promoted in collabration with Japanese based Daizo company; Australian based Pax company, is looking for potential team members lor new aerosol facility construction for personal care toiletries/ household/ FMCG/ Pharma manufacturing. The One Asia Network is looking to assemble a strong team with a predominantly oharmaceuticai background for project installation & associated QMS implementation along with a strong, successful startup & continued management of tine operations projectedfor trie Vapl/Daman Plant

Post: QA/QC Executive(05 posts), Production Supervisor(05 posts)

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ABOUT AUHTOR
Manish Patil*¹, Harsha D Jani¹, Suleman S Khoja², Narmin A Pirani³, Shamim S Khoja^3
1Department of Quality Assurance,
Shivam Pharmaceutical Studies and Research Centre, Anand
Gujarat, India.
²Resource person in pharmaceutical quality assurance and Audit Compliance, Vapi
³Registered Pharmacist, Gujarat, India
*manishpatil3194@gmail.com

ABSTRACT
This review article presents the pharmacology of combined Metformin hydrochloride and Teneligliptin hydrobromide hydrate is effective on type 2 Diabetes Mellitus. Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Teneligliptin, a third generation Dipeptidyl Peptidase-4 (DPP-4) inhibitor exhibits unique “J shaped” structure with “anchor-lock domain” mechanism which provides potent & long duration of action. The addition of teneligliptin once daily to Metformin was effective and generally well tolerated in Korean patients with type 2 diabetes. The mechanism of Metformin hydrochloride and teneligliptin hydrobromide hydrate is quite different. The main objective of this review article is to provide pharmacological and Analytical information of combination of Metformin hydrochloride and Teneligliptin hydrobromide hydrate to researcher in development of combined dosage form.