Tout sur les médicaments הכל על תרופות كل شيئ عن الأدوية Все о наркотиках 关于药品的一切 డ్రగ్స్ గురించి అన్ని 마약에 관한 모든 것 Όλα για τα Ναρκωτικά Complete Tracking of Drugs Across the World by Dr Anthony Melvin Crasto, Worldpeacepeaker, worlddrugtracker, PH.D (ICT), MUMBAI, INDIA, Worlddrugtracker, Helping millions, 9 million hits on google on all websites, 2.5 lakh connections on all networks, “ALL FOR DRUGS” CATERS TO EDUCATION GLOBALLY, No commercial exploits are done or advertisements added by me. This is a compilation for educational purposes only. P.S. : The views expressed are my personal and in no-way suggest the views of the professional body or the company that I represent
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The “e Manufacturing Execution System” for pharmaceutical manufacturing is different from eMES in any other manufacturing industry. The difference primarily comes from the stringent Regulatory Compliance norms to be adhered to in Pharmaceutical Operations. In the Pharmaceutical Manufacturing the eMES is also referred as eBMR or “e Batch Manufacturing Record”.
The key objectives of implementing “e Manufacturing Execution Systems” (or eBMR) in Pharma Manufacturing are:
Achieve Compliancewith global regulatory norms, quality processes and ALCOA + norms.
Achieve Data integrityacross functions, systems and equipment records.
Audit readiness: Become ever ready for audit, with complete electronic records.
Paperless operation: Achieve paperless (or less paper) operation at the plant.
Pharmaceutical companies operate in one of the most dynamic and highly regulated environments. Regulatory audit frequencies have increased. Warning letters & import restrictions incidences have increased alongside. Many companies fail in clearing Regulatory Audits. Failing an audit results in over two years of business loss and huge expenses in achieving success with re-audit.
Most of the Pharmaceutical Manufacturing organizations have realized that they must implement a comprehensive eMES/eBMR systems for achieving the stated objective for long term business survival in todays regulated environment. However, the existing infrastructure scenario, inhibit moving forward with such implementation.
The scenario: Many Pharmaceutical Manufacturing Units are supplying to strongly regulated markets. They have a mix of the following infrastructure scenario:
Obsolete Equipment: Some equipment are obsolete in their design. These have no digital ability to record and communicate critical operations parameters for recording into BMR.
Semi-modern equipment: Some equipment have some digital ability to show records but are not enabled for automatic data transmission to SCADA database.
Modern Equipment: Some equipment are modern, PLC controlled and they can store digital data for some time. They still need to be integrated to SCADA (Supervisory Control And Data Acquisition) system.
There are also several cases of failures in implementing eMES solution provided by global brands providing the MES solution. Some of the key reasons of eMES implementation project failures are:
Complexity of the eMESSoftware systems. The level of complexity that can be digested across continents vary a lot. What is simple for some European countries may be too complex for Asian countries.
Design and Architecture of MES Solutions: A generic MES, modified for Pharma, would not succeed in Pharma. The eMES must be designed for Pharmaceutical operations, where the regulatory compliance requires flexibility in system to allow special process steps, for which there is no global best practices. The system must be architected for allowing new recipe, new product and new process to be quickly configured.
Right collaboration: Very often IT Team of Pharma companies would be good at handling the ERP Software and Level 3 & Level 4 IT systems. They would lack expertise of Level 1 and Level 2 Automation. Companies need to get right IT Solution providers capable of supplying and implementation right eMES along with Automation Solutions.
Comprehensive Solution: A comprehensive solution design would encompass eMES, integration with ERP, integration with SCADA and direct integration with many devices. The SCADA and Automation solution would include upgrading the semi modern equipment, connecting them along with modern equipment to SCADA. Adopting right strategy solution for obsolete equipment.
Phased implementation Strategy: There is variety of strategies for eMES implementation with complete automation integration. Designing and selecting right strategy is a Critical Success Factor.
The country, the facility location, equipment vendors, employees, organization culture, the product and market combination etc., makes every unit and unique unit. The eMES solution must be designed to suit each such unit. One solution would not fit all. The solutions must be configurable for taking care of the uniqueness. The solutions must be robust and maintainable.
Laurel MES™ product suite for “e Manufacturing Execution” is architected and designed for Pharmaceutical Manufacturing businesses to achieve compliance and audit readiness. Laurel MES™ comes along with Automation Solution and Systems Integration Solution which provides a complete, comprehensive and configurable solution. The drug product variants, market variants and product changeover challenges are addressed as required. Management dashboards and scorecards are fascinating. This solution is integration-ready for latest manufacturing and testing equipment.
Experienced Chief Executive Officer with a track record of leading Architecture Design and development of Software Products for Pharma Manufacturing Execution, Pharma R&D and making it successful in the market. Demonstrated strength in the information technology, software technologies, software services, Pharma, Chemical and Engineering industry. Skilled in Business Process, Architecture and Design of Enterprise Software and Computer Integrated Manufacturing. Strong business development professional with Engineering and MBA qualifications.
Welcome to the PharmaCamp with Neha. With this video channel. I would like to spread knowledge about the pharmaceutical world. This is a small initiative from my side to share knowledge with the world, as I feel education is the best gift one can receive or give back to society. Are you a working professional who wants to upgrade your skills? OR a student who wants to make a career in pharmaceuticals? OR are you a person who is interested to learn about the regulatory systems? Then this YouTube channel is for you. In this video, we will about US FDA Investigational New Drug (IND) Application. In my upcoming video, I will provide the stepwise approach for these IND applications. Therefore, this video will serve as the basis for those upcoming videos to explain the concept of INDs.
About me: I am Neha Parashar, working as a Senior Manager in a pharmaceutical company and based in Germany. I am a passionate healthcare professional, an educator, and a mentor. LinkedIn: http://linkedin.com/in/neha-parashar
An Active Substance Master File (ASMF), or formerly known as European Drug Master File (EDMF) procedure, is a set of documents that protects the valuable confidential intellectual property of the manufacturer.
The main objective of the Active Substance Master File (ASMF) procedure, formerly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property or ‘know-how’ of the manufacturer of the active substance (ASM) to be protected, while at the same time allowing the Applicant or Marketing Authorisation (MA) holder to take full responsibility for the medicinal product and the quality and quality control of the active substance. National Competent Authorities/EMA thus have access to the complete information that is necessary for an evaluation of the suitability of the use of the active substance in the medicinal product.
Final Guideline on Active Substance Master File Procedure – Revision 4 (PDF/358.28 KB)
The ASMF holder may have an ASMF as well as a Certificate of Suitability (CEP) issued by EDQM for a single active substance. Generally, it is however not acceptable that the Applicant/MA holder refers to an ASMF as well as to a CEP for a single active substance of a particular MAA/MAV.
What is an ASMF in pharmaceutical industry?
The main objective of the Active Substance Master File (ASMF) procedure, formerly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property or ‘know-how’ of the manufacturer of the active substance (ASM) to be protected, while at the same time allowing the …
What is the difference between Asmf and DMF?
An Active Substance Master File (ASMF) is the currently recognised term in Europe, formerly known as European Drug Master File (EDMF) or a US-Drug Master file (US-DMF) in the United States.
What is a EDQM CEP certificate?
To obtain a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP), applicants must send in electronic format the following documentation to the Certification of Substances Department (DCEP) of the EDQM: a completed application form which includes your invoicing details.
Electronic Active Substance Master Files (eASMF)
ASMF Holders who are supplying substances to more than one Centrally Authorised Product (CAP) should submit their ASMF to the Agency once and not for each application.
The use of eCTD is mandatory for all for centralised procedure human ASMF submissions since 1 July 2016. The use of eCTD is mandatory for ASMFs used for DCP/MRP human procedures from 1 January 2018. Use of eCTD is mandatory for new national MAAs since 1 July 2018 and from 1 January 2019 for all other submission types. The relevant guidance should be followed and the technical eCTD validation criteria must be passed.
To ensure that the above is followed promptly, please refer to the human EMA Pre-authorisation guidance carefully and apply for an EMEA/ASMF/XXXXX number at your earliest convenience by submitting the EMEA/ASMF request form.
For veterinary medicines the accepted electronic format is VNeeS and NeeS and for ASMFs also exceptionally eCTD is allowed. More information can be found from the Veterinary Pre-submission guidance.
It is very important to note that the above two initiatives are different.
The EMA eASMF submission rules are mandatory since 1st September 2013 and are applicable to all Centralised applications.
The EU Assessment worksharing initiative is valid for Centralised and Decentralised procedures.
A valid ASMF should have either an EMEA/ASMF number or an EU/ASMF number, depending on the intended use of the ASMF by its holder. When applying for EMEA or EU ASMF numbers, or submitting any documentation quoting these, please note that they are not inter-changeable. Only one ASMF number should be quoted.
It is mandatory to use XML delivery files for ASMF submissions using the eSubmission Gateway and the Web Client.
Letter of Access Template (Previously Annex 2), Template Administrative Information – (Previously Annex 3), Template Withdrawal of Access Letter –Should be filled in in accordance of the ASMF type (EU/ASMF/XXXXX or EMEA/ASMF/XXXXX)
ASMF worksharing – Introduction to the procedure (October 2018)
Requesting an EU_ASMF repository number (October 2018)
Submitting an initial worksharing ASMF (October 2018)
Determining the parent procedure (October 2018)
Assessment report template (October 2018)
Sharing assessment reports (October 2018)
Submitting a variation to an ASMF (October 2018)
Use of an approved ASMF in a new procedure (October 2018)
An Active Substance Master File (ASMF), or formerly known as European Drug Master File (EDMF) procedure, is a set of documents that protects the valuable confidential intellectual property of the manufacturer. The purpose of an ASMF is to provide the Health Authorities (HAs) with complete information of the active substance used in a drug product to evaluate its suitability for the product. It also allows the Marketing Authorization Holder (MAH) of the product to take the responsibility for the quality of the active substance used in the product.
ASMF Content
An ASMF must contain all the scientific information related to the active substance. The information of an ASMF is divided into two parts:
Applicant Part (AP) – Contains information considered as non-confidential by the MAH
Restricted Part – Contains confidential information
ASMF Usage
An ASMF is submitted only to support a Marketing Authorisation Application (MAA) or Marketing Authorisation Variation (MAV). It is used for the following active substances:
Active substances that are new
Already existing active substances, which are excluded from the European Pharmacopoeia (Ph. Eur.)
Pharmacopoeial active substances, which are included in the (Ph. Eur.)
An ASMF holder is required to submit the following to the MAH holder:
A copy of AP’s latest version
A copy of the summary/detailed version of AP’s latest version
A copy of the letter of access, which has not been previously submitted for the same product
A single active substance can have both, an ASMF as well as a Certificate of Suitability (CEP). However, the MAH cannot refer to both the documents for a single active substance. In case, the information present in a CEP is insufficient, only then both the documents can be referred.
Follow the journey of a medicine for human use assessed by EMA in this interactive timeline. It explains all stages from initial research to patient access, including how EMA supports medicine development, assesses the benefits and risks and monitors the safety of medicine
From laboratory to patient: the journey of a centrally authorised medicine (PDF/1.75 MB)
First published: 04/03/2019
Last updated: 10/02/2020
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