good distribution practices (GDP) That part of quality assurance that ensures that the quality of a pharmaceutical product is maintained by means of adequate control of the numerous activities which occur during the distribution process as well as providing a tool to secure the distribution system from counterfeits, unapproved, illegally imported, stolen, counterfeit, substandard, adulterated. 81 manufacturing practices (GMP), good storage practice (GSP) and good distribution practice 82 (GDP) as applicable. 83 1.7. This guideline does84 not deal with dispensing to patients as this is addressed in the World 85 Health Organization (WHO) good pharmacy practice (GPP) guide (xx). These guidelines 86 should also be read in conjunction with other WHO guidelines (xx). 87 88 2. SCOPE 89 90.
Good Distribution Practices (GDP) Principles - the most important (GDP) The level of quality [of medicinal products] should be maintained throughout the distribution network. A tracing system should enable any faulty product to be found. There should be an effective recall procedure. 20.10.2009 Dr. Martin Melzer 15 Staatliches Gewerbeaufsichtsamt Hannover Good Distribution. GUIDANCE NOTES ON GOOD DISTRIBUTION PRACTICE AUGUST 2015 . 5.6 A record of receipt and distribution of the products shall be kept, stating the product name, date of transaction, invoice/delivery order number, name and address of purchaser/supplier, batch number, expiry date, quantity received/sold and stock balance. 5.7 Documents shouldbe retained for a duration as in accordance with the legal. 1083 Good Distribution Practices—Supply Chain Integrity. Because there is no information in the USP-NF on this subject, a new general information chapter is being proposed. This new chapter will be a part of the series of information chapters describing various aspects of the pharmaceutical supply chain. The current official chapter in this series is Good Storage and Shipping Practices. GOOD DISTRIBUTION PRACTICE Author: jkaconsu-massadl Created Date: 2/2/2014 4:47:16 PM.
steps such as repackaging or relabelling, the principles of Good Manufacturing Practice (GMP) should be applied to these processes. This guideline is applicable to all organisations and individuals involved in any aspect of the storage and distribution of products/cosmetics including but not limited to the following: Manufacturers of active pharmaceutical ingredients, drug products. on principles of Good Distribution Practice of active substances for medicinal products for human use (Text with EEA relevance) (2015/C 95/01) Introduction. These guidelines are based on the fourth paragraph of . Article 47. of . Directive 2001/83/EC (1). They follow the same principles that underlie the guidelines of EudraLex Volume 4, Part II, Chapter 17, with regard to the distribution of. Unter Good Distribution Practice (GDP) versteht man die Summe der Maßnahmen, die durch eine Kontrolle der Vertriebskette sicherstellt, dass die Qualität und Unversehrtheit von Arzneimitteln aufrechterhalten wird . Discussion Forum Downloads GDP Supplier Database Information for Members Code of Practice for RPs Downloads As a GDP member you will find here a selection of interesting documents to download
Good Distribution Practices (GDP) -Regulation & Drivers Good Import Practices (GIPs) Distribution Control Systems (DCS) Good Cold Chain Practices (GCCPs) GDP. 8 Updated and Newly Issued Regulations and Guidelines Reg u l at o r y Gu i d an c es A r g en t i n a Eg y p t Romania Australia FDA Sau d i A r ab i a Austria ICH Singapore Brazil India (IPPO) S. Africa Can ad a Ireland S. Korea. Discussion Forum Downloads GDP Supplier Database Information for Members Code of Practice for RPs Good Distribution Practice (GDP) Guidelines The following Guideline Tree contains the most important Guidelines on Good Distribution Practices (GDP Good Distribution Practice (GDP) is that part of quality assurance which ensures products are consistently stored, transported and handled under suitable conditions as required by the marketing authorisation (MA) or product specification Good Distribution Practice (GDP) DEKRA Certification GmbH bescheinigt hiermit, dass die Organisation TNT Express GmbH Zertifizierter Bereich: Abholung, Umschlag, Zustellung von humanmedizinischen Produkten im temperaturgeführten und nicht temperaturgeführten Bereich. Zertifizierter Standort: Haberstraße 2, 53842 Troisdorf, Deutschland (weitere Standorte siehe Anhang) ein System zur.
Reasons for change: The content of the Guidelines on Good Distribution Practice published in 1994 is no longer adequate. It needs to be reviewed to take into account advancements of practices for an appropriate storage and distribution of medicinal products in the European Union. Moreover, it should take into account the amendments to the Community Code which have been introduced with. A revised version of the Guidelines on Good Distribution Practice of Medicinal Products for Human Use was published in the Official Journal and is applicable as of 24 November 2013 (OJ C 343/1, 23.11.2013). Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (all language versions are available here). These.
HPRA Guide to Good Distribution Practice of Medicinal Products for Human Use IA-G0046-6 8/37 change, including processes, equipment, personnel, training, validation, quality system and regulatory implications. The required actions to give full effect to the change and ensure its implementation should be identified and assigned to relevant personnel. In addition, changes should be formally. Die gute Vertriebspraxis oder Good Distribution Practice (GDP) ist Teil der Qualitätssicherung. Sie soll gewährleisten, dass die Qualität von Arzneimitteln während sämtlicher Etappen der Lieferkette erhalten bleibt. Unsere Fachliteratur zum Thema GDP unterstützt Sie und gibt Ihnen Sicherheit für das tägliche Handeln .pdf 12.03.2008 16:04:44 Uhr Das Projekt Flexiﬁ x 24/7 wird im Rahmen des Programms Fachkräft e sichern durch das Bundesministerium für Arbeit und Soziales und den Europäischen Sozialfonds gefördert..pdf 12.03.2008 16:04:44 Uh Good distribution practice (GDP) requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by..
GxP: Acronym for the group of good practice guides governing the preclinical, clinical, manufacturing and post-market activities for regulated pharmaceuticals, biologics, medical devices, etc., such as good laboratory practices, good clinical practices, good manufacturing practices and good distribution practices Warehouse and Distribution Centres: 2018 Best Practice Discover the latest industry trends and find out how to improve your key metrics Stewart Campbell, Avery Weigh-Tronix. 2 Introduction Warehouses and distribution centres (DCs) play a key part in the supply chain. However, in such a fast-paced environment it can be challenging for warehouse managers to continually deliver successful.
<1079> GOOD STORAGE AND SHIPPING PRACTICES-General Chapters 1079 GOOD STORAGE AND SHIPPING PRACTICES This general information chapter is intended to provide general guidance concerning storing, distributing, and shipping of Pharmacopeial preparations. It describes procedures to maintain proper storage environments for individual articles and to ensure a preparation's integrity, including its. Good Distribution Practice (GDP) DEKRA Certification GmbH bescheinigt hiermit, dass das Unternehmen TNT Express GmbH Zertifizierter Bereich: Abholung, Umschlag, Zustellung, Ein- und Ausfuhr von humanmedizinischen Produkten im nicht temperaturgeführten Bereich Zertifizierter Standort: D-53842 Troisdorf, Haberstraße 2 (weitere Standorte siehe Anhang) ein System zur Einhaltung der Regeln der. GOOD DISTRIBUTION PRACTICES FOR PHARMACEUTICAL PRODUCTS Document No : CDSCO/GDP.PP Ver. : 00 Effective Date : Central Drugs Standard Control Organization Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India FDA Bhawan, ITO, Kotla Road, New Delhi -110002. Published on the website of www.cdsco.nic.in on 10/01/2013 Notification The following draft. Guideline on Good Distribution Practice (Third Edition, 2018) Posted By Jauze 01 January 2018 Hits: 17540. Print Email User Rating: 4 /.
Chapter <1079> Good Storage and Distribution Practices for Drug Products. Our comments are summarized in the accompanying table. We hope you find these useful. We would be happy to provide any additional information or explanation, if required, Please let me know if you have any questions. Yours Sincerely, Robert P. Best . President/CEO . ISPE . Regulatory Comment Form Proposed Regulation. and Good Distribution Practices: Program and Activities in Indonesia Presented in Joint Symposium PMDA Japan -Badan POM RI, In Collaboration with GP FARMASI Indonesia Jakarta, 13 Februari 2013 RAJA AMPAT, PAPUA - INDONESIA To be INNOVATIVE, CREDIBLE, INTERNATIONALLY RECOGNIZED INSTITUTION on DRUG AND FOOD CONTROL to PROTECT PUBLIC HEALTH. European Chemical Industry Counci Good distribution practices (GDP) is an essential concept of pharmaceutical SCM to ensure systematic distribution of medicinal products from manufacturing site to retailers. The main concerns arising during pharmaceutical distribution are: deterioration, counterfeit drugs and pilferages. The GDP guidance is the most relevant standard which governs the quality system during pharmaceutical. Good storage and distribution practices apply to all orga-nizations and individuals involved in any aspect of the stor- The holder of the drug product application, the drug age and distribution of all drug products, including but notproduct manufacturer (in the case of many OTCs, where limited to the following: there is no application) and the repackager bear primary • Manufacturers of drug.
Good Warehousing Practices (GWH) in Pharmaceutical Industry 1. GOOD WAREHOUSING PRACTICES (GWP) 1 Mr. Swapnil Karale -M.Sc. DPQCQAM, DDRA STAC Academy 2. ABOUT TRAINER(MR. SWAPNIL KARALE) Mr. Swapnil is managing, leading & positively contributing in the area of documentation, systems set up and enhancements, quality assurance, auditing. Regulations 2012 as amended (HMR) and European Commission Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) (EU GDP) are included; those performed as part of GMDP inspections are not included. The data is presented graphically followed by illustrative examples of deficiencies against the Human Medicines Regulations 2012 and deficiencies against GDP. Has PDF. Publication Type. Author. More Filters. More Filters. Filters Quality Inadequacies in Supply Chain Management of Pharmaceutical Products-A Preliminary Study in India. N. Kumar, A. Jha, B. Bora, A. Adhikary; 2017; Save. Alert. Research Feed. References. SHOWING 1-10 OF 10 REFERENCES [Documentation of good distribution practice of medicines and its implementation in Lithuanian drug. GDP: Good distribution practices . GMP: Good manufacturing practices . ICH: International Council for Harmonisation . MAH: Market authorization holder . MKT: Mean kinetic temperature . PIC/S: Pharmaceutical Inspection Cooperation Scheme . QRM: Quality risk management . Terms. The following definitions apply to the terms used in these guidelines. They supplement the definitions provided in the.
•CDSCO (India) -Guidelines on Good Distribution Practice for Biological Products (2012) •CFDA (China) -Good Supply Practices for Pharmaceutical Products (2013) •EMA -(2013/C 68/01) Good Distribution Practice of Medicinal Products for Human Use •USP 36 -Chapter <1079> Good Storage and Distribution Practices for Drug Products •WHO Technical Report Series, No.961, 2011 Annex 9. Good distribution practice IP border measures S-STANDAD ASI-IED Action by market surveillance & enforcement authorities Waste management CONE-EI Domestic distribution & surveillance Distribution Testing Metrology IP border measures Iter) ustoms S Cold chain integrity COVID-19 ADE CONOS Source: WTO, based on EMEA, IFPMA. For clarity of presentation, the different steps in the vaccine value.
. 2011; First publication date: 2008 Version: 2. The IPEC Excipient Stability Program Guide. 2010; First publication date: 2010 Version: 1 . The IPEC-PQG Good Manufacturing Practices Audit Guideline. 2008; First publication date: 1995 Version: 3. Guidelines. IPEC Europe develops and publishes guidelines to promote the best use of excipients. Unter Gute Herstellungspraxis (englisch Good Manufacturing Practice, abgekürzt GMP) versteht man Richtlinien zur Qualitätssicherung der Produktionsabläufe und -umgebung in der Produktion von Arzneimitteln und Wirkstoffen, aber auch bei Kosmetika, Lebens-und Futtermitteln.In der pharmazeutischen Herstellung spielt die Qualitätssicherung eine zentrale Rolle, da hier Qualitätsabweichungen. The quality risk management during pharmaceutical good distribution practices helps effective management of quality risks to ensure supply continuity is a significant challenge has following key steps: i. Make quality and risk management as key elements during supply chain. ii. Identify the supply chain quality risk through holistic approach. iii. Establish risk mitigation tools during supply. Good Distribution Practices (/GDP) requirements applicable to the storage and distribution food industry sector. Sites must meet the requirements of the module that are applicable to their operation. The four appendices in the SQF Code provide additional information needed to implement an SQF System: o Appendix 1: SQF Food Sector Categories o Appendix 2: Glossary of Terms o Appendix 3: SQF. The 'Good Distribution Practice for Medical Device in Singapore' is a regulatory framework initiated by SAC (Singapore Accreditation Council) to support the Health Products Act 2007 by HSA (Health Science Authority) GDPMDS is a mandatory audit for any organizations involved with importing, wholesale and distribution of medical devices prior to their license application. Why do I need it.
Provide stand-alone guidance on Good Distribution Practice (GDP) To be followed by Importers and distributors of active substances for medicinal products for human use. Distributors of active substances manufactured by themselves. Complement rules on distribution set out in the guidelines of EudraLex Volume 4, Part II 3/29/2015 5 Drug Regulations - Online Resource latest information. 6. You can find information about good distribution practice (GDP) in the: GDP executive order no. 1541 of 18 December 2019 on distribution of medicinal products (retsinformation.dk) (in Danish only) More detailed guidance on distribution appears from the Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (eur-lex.europa.eu A WHO guide to good manufacturing practice (GMP) requirements Part 1: Standard operating procedures and master formulae Written by: Gillian Chaloner-Larsson, Ph.D, GCL Bioconsult, Ottawa Roger Anderson, Ph.D, Director of Quality Operations, Massachusetts Public Health Biologic Labs Anik Egan, BSc.,GCL Bioconsult, Ottawa In collaboration with: Manoel Antonio da Fonseca Costa Filho, M.Sc. 4.1.1 Good Manufacturing Practice Good manufacturing practice (GMP) is that part of quality management which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use. GMP is concerned with both production and quality control. The basic requirements of GMP are that: (i) All manufacturing processes are clearly defined.
Good Pharmacy Practice Manual and Associated SAPC rules 2018: South African Pharmacy Council 6 2.1 Introduction 2.2 Minimum standards for manufacturing of any medicine or scheduled substance 2.3 Minimum standards for procurement, storage and distribution 2.3.1 Responsibility for procurement 2.3.2 Sources of supply 2.3.3 Safe systems of wor The Guide discusses how LPG cylinders travel through distribution channels and why good control is needed for the consumer to receive and use the product in a safe and sustainable way. To illustrate this the Guide uses some photos to show examples of good practices. The Guide explains the importance of asset ownership and the responsibilities that are associated with that, especially the issue. Good Distribution Practices or GDP means that part of quality assurance which ensures that the quality of a pharmaceutical product is maintained through adequate control throughout the numerous activities which occur during the distribution process. 7. Good Manufacturing Practice or GMP means that part of quality assurance which ensures that medicinal products are consistently produced. Good Manufacturing Practices SA Guide to GMP 4.01_SA Guide to Good Manufacturing Practice_Jul19_v97 July 2019 Page 1 of 18 Back to ToC SA GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINES This document is intended to serve as guidance on the requirements for Good Manufacturing Practice (GMP) in South Africa. This guideline is not intended as an exclusive approach. SAHPRA reserves the right to. The Good Distribution Practices (GDP) is considered an essential basis of pharmaceutical SCM to ensure systematic distribution of medicinal products. Due to lack of proper understanding and.
FOOD SAFETY AND GOOD HYGIENIC PRACTICES HANDBOOK FOR GAMBIAN YOUTH ENTREPRENEURS . INTERNATIONAL TRADE CENTRE ii October 2017 Banjul, and Geneva Under the supervision of Khemraj Ramful, Senior Adviser, Export Quality Management, this guide on food safety has been prepared by Hema Menon, Trade Training Officer, at the International Trade Centre, in partnership with The Food Safety and Quality. and distribution is essential for the attainment of quality. The quality objective [shall] be achieved by an integrated system which includes Quality by Design, Quality Control, Quality Assurance and Good Manufacturing Practice. 2.1 Quality by Design An important aspect of quality management is the concept of quality by design. This means that quality is built into a product from the very. Procedural Guidance for Industry - Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs. .09.2019) OS000_00_021e_MB Flyer eGov GMP-GDP service (PDF, 246 kB, 13.09.2019) Certificate Wholesalers are responsible for effective, efficient and safe handling, storage and distribution of such products. On the other hand retailers are the final/contact personnel with the clients/patients. As such, these guidelines set out appropriate steps for meeting these responsibilities. Current Good Distribution Practices for pharmaceutical products incorporates and provide for minimum.
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from good distribution practice also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDP / GDocP standards are codified by various competent authorities, others are not but are. Good Distribution Practice (GDP) • Applies to all drugs including active pharmaceutical. ingredients, excipients, intermediates and finished. goods. • With such protocol in mind, a level of quality exists. throughout the distribution network so that authorized. medicinal products are distributed without any good distribution practice requirements for the uploaded file is to patient safety as they might, where seals are due to be a qms. Unless it a serious impact on focussing on production, the good practices. Rx and distribution practices checklist can do their supply of gdp. Hit the good distribution checklist is not be uploaded file for inspection unless it is it is integral to browse this post. Good Distribution Practice (GDP) DEKRA Certification GmbH hereby certifies that the organization General Logistics Systems Denmark A/S Scope of certification: International and domestic parcel and freight logistics Certified location: Kokmose 3, 6000 Kolding, Denmark (further locations see annex) has introduced and is maintaining a system to ensure compliance with the rules of the EU. The current study analyses the regulatory inspection findings of the wholesalers in Bulgaria in 2017 and compares the results with the findings from some other EU member-states. In total, 48 GDP inspections were performed in 2017. 50% of the inspections were performed in relation with issuing an authorization for wholesale of medicines, the rest half were related to changes in already granted.
order to determine the level of compliance with Good Manufacturing Practice ( GMP) 96 and Good Distribution Practice (GDP) principles. These inspections are commonly 97 performed onsite however may- be performed through the remote or off-site 98 evaluation of documentary evidence, in which case the limitations of remote review 99 of data should be considered. 100 2.2 The effectiveness of these. . for the Use of Mothers and Teachers Click the hyperlink under to download and read Kindergarten Culture in the Family and Kindergarten; A. Good Distribution Practices (GDP) is a quality system for warehouse and distribution centers dedicated for medicines. Internationally accepted pharmaceutical GDP regulations stipulate that distributors of pharmaceutical products must align their operations with the standards. The scheme ensures that consistent quality management systems are in place throughout your entire supply chain, from the early delivery of raw materials to the manufacturing plants, to the final shipment of finished. This document, Tea Primary Processing Good Manufacturing Practice (GMP) preparation and distribution techniques have developed to reflect this. Effective hygiene control, therefore, is vital to avoid the adverse human health and economic consequences of food-borne illness, food-borne injury and food spoilage. Everyone, including farmers and growers, manufacturers and processors, food. Good Manufacturing Practices (GMPs) are regulations that describe the methods, equipment, facilities, and controls required for producing: Human and veterinary product
PIC/S Guide to Good Distribution Practice (GDP) for Medicinal Products : PE 011-1: Documents for Inspectors: Guidance documents: Press Release May 2014 : PR May 2014: Documents for the public: Press releases: Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments : PE 010-4: Documents for Inspectors: Guidance document Quality Risk Management (QRM) is a requirement of Good Distribution Practice (GDP). It underpins good design and maintenance of a GDP quality system and provides an approach that enables the quality system to be safe for patients, efficient and effective through identification of risks, and facilitates proportionality of mitigation Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of documents. The importance of documentation: As per GMP documentation control If it is not written down, then it did not happen. The document provides information on when, where, who, why and how to complete the task. The document provides evidence proving that the tasks have been completed as they should be
GOOD STORAGE PRACTICES • The special measures that need to be considered in the storage and distribution of product, such that the products will be of the nature and quality intended when it reaches the consumer • Specific procedures for : receiving storage distribution of materials/cosmetic products DEFINITION OF GSP . 1. Premises/warehouse 2. Storage Facilities 3. Personnel 4. Stock. Best-practice companies manage the put-away area by calculating resource and space requirements based on expected receipts and current backlogs. Best practice is to put away product the same day it's received, because not doing so affects space, causes congestion, increases transaction errors, and makes product more susceptible to damage. In a busy warehouse, it is easy to let product put-away fall behind other tasks such as picking, replenishment, shipping, and loading. But. A GOOD PRACTICE SOURCEBOOK DRAFT WORKING DOCUMENT December 2012 This working document was prepared by Asian Development Bank staff. It does not provide an exhaustive or definitive treatment of the issues. Its interpretations and contents do not necessarily reflect the views of the ADB's Board of Governors and the governments they represent. The Asian Development Bank does not guarantee the. View Good Warehouse Practices PPTs online, safely and virus-free! Many are downloadable. Learn new and interesting things. Get ideas for your own presentations. Share yours for free Good clinical practice (GCP) is a set of internationally-recognised ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting clinical.
Good Distribution Practices are a natural extension of Good Manufacturing Practices, Good Clinical Practices and Good Laboratory Practices, among other requirements for manufacturers of medicinal products and devices. Regulations and guidance for each different custodian in the supply chain can vary by country, state and province. For example: • The United States Pharmacopeia (USP) Chapter. Good Documentation Practice (GDP) routinely used within the pharmaceutical industry - as best practice standards or as a direct requirement of the Code of Good Manufacturing Practice (GMP). PharmOut white paper: How to implement Good Documentation Practices PharmOut Pty Ltd, ABN: 85 117 673 766, Unit 10, 24 Lakeside Drive, Burwood East, Victoria 3151. Ph: +61 3 9887 6412, Fax: +61 3 8610. The Good Practice Guidelines (GPG) 2018 Edition is the definitive guide for business continuity and resilience professionals. The GPG is used as an information source for individuals and organizations seeking an understanding of business continuity as part of their awareness raising campaigns and training schedules. The GPG takes a collaborative approach to business continuity, ensuring. EUROPEAN COMMISSION Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (Text with EEA relevanc to good practice that have been used in different kinds of settings in the last few years. In addition, the power-ful implications of these principles for the way states fund and govern higher education and for the way institutions are run are discussed briefly at the end. As faculty members, academic administrators, and srudent personnel staff, we have spent most of our working lives trying.
framework of the DABLAS Task Force1, and provides guidance regarding good practice in project preparation for the reform and financing of water utilities that are publicly owned or controlled by local or regional governments. It is divided into two key sections: I. Key features of good project preparation - this section provides a summary overview of key features to be addressed for good. Best practice distribution centers integrate operations with their suppliers. This way, suppliers help them achieve maximum throughput and maximum efficiency, in a minimum amount of time, Derewecki says. Working with suppliers so they provide product configured for easy handling within your facility is key. A vendor compliance program needs to be a collaborative effort that involves. Nexdigm (SKP) | Business Set-up, Transaction Support. Good Documentation Practices (GDocP) | GMP Basics GMP Basics of Good Documentation Practices (GDocP). Good documentation practices (GDocP) are key components of GMP compliance. Good record-keeping not only helps you during regulatory inspections (GMP audits), it is mandatory to ensure your documentation practices — and your products — meet industry standards and legal requirements for. The following rules of Annexure A of the Rules relating to good pharmacypractice are amended: (a) Rule 1.2.1; (b) Rule 18.104.22.168; (c) Rule 22.214.171.124; (d) Rule 4.3.6; and (e) Annexure A: Scope of practice of Pharmacy Personnel - Authority, duties and responsibilities of the Responsible Pharmacist. 3. The following minimum standards as published herewith shall constitute additiona
Good Documentation Practices (GDP) in Pharmaceuticals Learn how to follow Good Documentation Practices in Pharmaceutical Quality Assurance, Quality Control and Production. Ankur Choudhary Print Question Forum 2 comments 1. All documentation entries shall be made with indelible black ink in clear and legible handwriting. 2. Verification of the Document made by QA by using indelible blue ink. 3. Good Documentation Practice (Gap): Coordinate Regulatory Requirements in Pharmaceutical Manufacturing Industry Joymalya Bhattacharya, M.Pharm (Pharmaceutics), Mba (Hrm), M.Phil (Management) Senior Chemist, Albert David Limited.5/11,D.Gupta Lane, Kolkata-700 050, India Abstract: Basic Rules In Any Good Manufacturing Practice (Gmp) Regulations Specify That The Pharmaceutical Manufacturer Must. Good manufacturing practices (GMP) ensure that drugs meet the quality standards appropriate to their intended use before they are sold. To ensure compliance with GMP regulations, the Health Product Compliance Directorate (HPCD) inspects establishments that fabricate, package or label, distribute, import, wholesale or test drugs Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs. 21 CFR Part 211. Current Good Manufacturing Practice for Finished Pharmaceuticals. 21 CFR Part 212.