Pharmacovigilance Guidance Document Version 2.0

This Pharmacovigilance Guidance Document for MAHs of Pharmaceutical Products in India is in accordance with the objective of Drugs and Cosmetics Act, 1940 & Rules, 1945 including NDCT Rules 2019. This guidance document is prepared by the National Coordination Centre (NCC)-Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission (IPC) in collaboration with Central Drugs Standard Control Organization (CDSCO) to facilitate submission of the safety profile of drugs by MAHs (MAH refers to manufacturer, marketer or the importer of the drug, who has valid manufacturing, marketing or import licence in India). This guidance document defines the roles & responsibilities of CDSCO, State(s)/UT(s) Drugs Controller, NCC-PvPI, IPC and MAHs in preparation of Pharmacovigilance System Master File by MAHs, Post Marketing Surveillance of Pharmaceutical Products, Preparation & Submission of Periodic Safety Update Report (PSUR), Quality Management System (QMS) at MAH organization, Audits and Inspection of Pharmacovigilance System at MAH organization and submission of Risk Management Plan, wherever applicable. This guidance document also provides assistance to MAHs on establishing and ensuring an elective Pharmacovigilance System at their organization. This guidance document may be amended from time to time after obtaining necessary approvals from the concerned authorities. To publish the Pharmacovigilance Guidance Document for MAHs of Pharmaceutical Products, Version 2.0, Expert Committee was constituted. 

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How to take Shimadzu HPLC backup and retore it (In Hindi)

GMP MANUAL: GMP-Verlag Peither AG

 

GMP MANUAL Volume 1 Manufacturing Production; Packaging; Laboratory and Analytical Control and Documentation

ISBNs: 9783934971745(ISBN-10: 3934971741)

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Handbook of Investigation and Effective CAPA Systems

Worldwide regulatory agencies perform many inspections annually, and all too often investigation and CAPA system violations are at the top of the list of infractions. Life-sciences regulated companies (not only FDA-regulated ones) must ensure their investigation and CAPA systems look beyond the ‘usual suspects' to identify other quality issues in order to minimize risks (including safe ones) and reduce costs.

Enhancements to this third edition include:

A new section linking the investigation and CAPA programs with the overall quality culture of the company

Fully updated, current versions of regulations including U.S. FDA, EU, ISO 9001, and ISO 13485

Updated inspectional observations from the U.S. FDA and U.K. MHRA

A revised investigation and CAPA processes chapter, which has an improved barrier analysis section, including detailed flowcharts describing the barrier analysis process

New charts and information related to the investigation of human errors; the human factor section includes information about training and competence

A new chapter devoted to analytical laboratory investigations, including a section covering the invalidation of testing results

Updated forms and examples of the different elements of the investigation and CAPA plan, including new case studies; a revised diagnostic tool used for investigating human error

Jose(Pepe) Rodrguez-Perez, PhD, is president of Business Excellence Consulting, Inc., (BEC), a Puerto Rico-based, consulting, training, and remediation firm that focuses on the areas of regulatory compliance, FDA-regulatory training, and risk management. He is a biologist with a doctoral degree in biology from the University of Granada (Spain). Over his career, he has served as an educator, a technical services manager, and as a science advisor to the FDA.

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Pharmaceutical Quality Assurance guidelines, 10th edition

The 10th edition of the Quality assurance of pharmaceuticals: a compendium of guidelines and related materials is an essential resource for the global healthcare community, designed to strengthen pharmaceutical standards worldwide.

The compendium, developed for national regulatory authorities, pharmaceutical manufacturers, healthcare professionals, and procurement agencies, is instrumental in upholding the globally acceptable standards of good manufacturing practices (GMP) and inspections. With forty-six guidelines, including eight new and ten revised ones, it provides a comprehensive framework for enhancing regulatory systems and international standards for pharmaceutical quality assurance.

The recent alerts on contaminated paediatric syrup medicines underline the urgency for strengthened measures in pharmaceutical manufacturing and for Member States to enforce these international standards to safeguard public health. Applying internationally acceptable standards supports local and regional production of medicines and the quality and safety of medicines circulating in international commerce.

In the context of global healthcare, the 10th edition of the WHO Quality Assurance of pharmaceuticals compendium, volume 2, is a commitment towards ensuring the quality, safety, and efficacy of pharmaceuticals worldwide. The compendium is one of several WHO initiatives aimed to strengthen quality assurance and access to medicines.

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Commerce Ministry to Implement Online System for Tracing & Authentication of Export From April, 2020

The Union Ministry of Commerce, through the Centre for Development of Advanced Computing (C-DAC), will implement online system for tracing and authentication of pharmaceutical export packages from April 1, 2020.

The online system is envisaged to help manufacturers and merchant traders to generate and utilise tertiary and secondary level coded data in a user-friendly manner. 

“Industry is very happy with the government initiative which will solve problems for track and trace,” says Nipun Jain, chairman, SME panel, Pharmexcil.

Simplified tracing system for authentication of drug packages will act as a single window integrated system that will enable the tracing of an exported pharmaceutical product. It has the provision to upload product and production data.

It also has provisions to create virtual tertiary and secondary packages and generation of unique identification for manufacturers,  merchant exporters (Labeler Code), products (Product Code), and Packages (Package Code- Primary, Secondary, Tertiary Packs). 

It will also help in tracing of pharmaceutical product exported using Unique ID and QR Code. 

System is based out of simplistic workflow and hence takes care of both manufacturers and merchant exporters. 

With this system, tertiary and secondary packing will be taken care with their corresponding unique serial numbers and there is no need of duplication of SSCC and tertiary generated by proposed system.

The proposed system is for Indian government’s tracing and tracking mechanism for export purposes, therefore it is independent of the product coding systems used by a manufacturer.

It facilitates ease of tracking of packages and products using Unique ID. An App shall be provided to verify product details upon entering unique Id.

The proposed system shall provide feasibility of generation of primary codes from software to printing systems directly and avoid manual or third party intervention. E-sign of Government of India shall be used (Aadhar based) instead of digital signatures. For products verification, the listing may be taken from authentic source like SUGAM, Central Drugs Standard Control Organisation (CDSCO). 

"Digital Link Syntax” - A new #GS1 Standard for Product Authentication

GS1 has recently published their technical guideline for Verification Router service where they intended to provide a simple standardized lightweight messaging framework for verification of saleable return and enables wholesaler/distributor to determine what immediate action should be taken based on authentication check.

Under the Drug Supply Chain Security Act, beginning November 27, 2019, wholesaler distributors are required to verify the product identifier of returned product before placing them into inventory for resale. A manufacturer who receives a verification request from a repackager, wholesale distributor, or dispenser must respond to that request within 24 hours. Supply chain parties are expected to exchange information in “a secure, interoperable, electronic manner in accordance with the standards

 GS1 advances with Digital Link Syntax

First time GS1 standard is including JSON as a message response syntax; it is also the first GS1 “Share” standard to leverage the new GS1 Digital Link (Web URI) standard for the request syntax.

GS1 technical standard to make use of the new GS1 Digital Link syntax in order to enable a basic automated authenticity check of a serialized product identifier with batch and expiry date via a lightweight web-based request/response message pair, initiated by a simple HTTP/HTTPS GET request and returning a lightweight machine-readable response message formatted in JavaScript Object Notation (JSON). 

In current practice, a product is uniquely identified by following elements and encoded in GS1 2D DataMatrix barcode.

(01)00361414567894(17)220228(10)E1908672(21)721234567872

 (01){gtin}(17){exp}(10){lot}(21){ser}

The GS1 Digital Link (Web URI) syntax provides an alternative way to express GTIN, serial number, lot/batch and expiry date within a single Web URI format. GS1 element strings can also be translated into a GS1 Digital Link Web URI with the following structure or URI template:

https://id.gs1.org/gtin/{gtin}/lot/{lot}/ser/{ser}?exp={exp}

where

{gtin}, {exp}, {lot} and {ser} are placeholders for the actual values, such as:

Example

https://id.gs1.org/gtin/00361414567894/lot/ E1908672/ser/721234567872?exp=220228

The GS1 Digital Link syntax is simply an alternative way of expressing a concatenation of one or more GS1 element strings but formatted in a way that functions as a web address. It is important to note that the GS1 Digital Link syntax does not require any changes whatsoever to current practices of marking products with GS1 barcodes, whether 1-D or 2-D; pharmaceutical packages will continue to be marked using GS1 DataMatrix symbols that encode the four elements above.

As part of the adoption strategy for GS1 Digital Link, GS1 is currently developing free open source translation functions (in JavaScript, PHP and Java) that will enable translation between GS1 element strings and the GS1 Digital Link / Web URI syntax, in both directions. This can then be included within the software / firmware of barcode scanners or further downstream, within information systems, so that the GS1 Digital Link / Web URI syntax can always be generated on demand, whenever it is required, without requiring any change to how GS1 identifiers are currently encoded and marked on product packaging. In other words, it will be possible to scan a set of four element strings (GTIN, Lot/Batch, Serial Number and Expiry Date) from an existing GS1 DataMatrix barcode on a product package, and have that GS1 element string translated into a GS1 Digital Link Web URI format whenever it is useful to do so.