--- product_id: 40959884 title: "Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017: Orange Guide" price: "656.94 DT" currency: TND in_stock: true reviews_count: 5 url: https://www.desertcart.tn/products/40959884-rules-and-guidance-for-pharmaceutical-manufacturers-and-distributors-2017-orange store_origin: TN region: Tunisia --- # Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017: Orange Guide **Price:** 656.94 DT **Availability:** ✅ In Stock ## Quick Answers - **What is this?** Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017: Orange Guide - **How much does it cost?** 656.94 DT with free shipping - **Is it available?** Yes, in stock and ready to ship - **Where can I buy it?** [www.desertcart.tn](https://www.desertcart.tn/products/40959884-rules-and-guidance-for-pharmaceutical-manufacturers-and-distributors-2017-orange) ## Best For - Customers looking for quality international products ## Why This Product - Free international shipping included - Worldwide delivery with tracking - 15-day hassle-free returns ## Description Familiarly known as the Orange Guide, this title is an essential reference work for all those involved in the manufacture and distribution of medicines in Europe. It is compiled by the UK drug regulatory body, MHRA, and brings together the European and UK guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use. It contains EU guidance on good manufacturing and good distribution practice along with relevant information on EU and UK legislation. Changes in this new edition: Revised Annex 15. The revision of Annex 15 takes into account changes to other sections of the EudraLex, Volume 4, Part I, relationship to Part II, Annex 11, ICH Q8, Q9, Q10 and Q11, QWP guidance on process validation, and changes in manufacturing technology. Revised Annex 16. The GMP Guide Annex 16 has been revised to reflect the globalisation of the pharmaceutical supply chains and the introduction of new quality control strategies. The revision has been carried out in the light of Directive 2011/62/EU amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of falsified medicinal products. This version also implements ICH Q8, Q9 and Q10 documents, and interpretation documents, such as the manufacturing and importation authorisation (MIA) interpretation document, as applicable. Also, some areas, where the interpretation by Member States has not been consistent, have been clarified. This revised Annex came into operation 15 April 2016. The introduction of guidelines on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities. The introduction of guidelines on the formalised risk assessment for ascertaining the appropriate GMP for excipients. The addition of the Guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01). These guidelines provide stand-alone guidance on Good Distribution Practice (GDP) for manufacturers, importers and distributors of active substances for medicinal products for human use. These guidelines should be followed as of 21 September 2015. The addition of the principles and guidelines of Good Manufacturing Practice (GMP) for active substances for medicinal products for human use, including active substances intended for export. Revisions to the UK Human Medicines Regulations 2012. MHRA GMP Data Integrity Definitions and Guidance for Industry is now included which sets out MHRA expectations for data integrity in good manufacturing practice (GMP). The Guidance complements existing EU GMP guidance and should be read in conjunction with national medicines legislation and the GMP standards published in Eudralex volume. Review: Buen producto recomendable - Buen producto y servicio recomendable Review: Easy to use - Easy to use and didn't encounter any problem. ## Technical Specifications | Specification | Value | |---------------|-------| | Best Sellers Rank | #7,186,291 in Books ( See Top 100 in Books ) #525 in Distribution & Warehouse Management (Books) #542 in Pharmaceutical & Biotechnology Industry (Books) #1,649 in Pharmacy (Books) | | Customer Reviews | 4.7 out of 5 stars 34 Reviews | ## Images ![Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017: Orange Guide - Image 1](https://m.media-amazon.com/images/I/715qKvC7QiL.jpg) ## Customer Reviews ### ⭐⭐⭐⭐⭐ Buen producto recomendable *by J***X on September 4, 2019* Buen producto y servicio recomendable ### ⭐⭐⭐⭐⭐ Easy to use *by A***R on April 22, 2017* Easy to use and didn't encounter any problem. ### ⭐⭐⭐⭐⭐ Clear and concise guidance *by C***H on April 17, 2019* Essential reference for manufacturers and distributors of medicines in Europe. Easy to read and understand. --- ## Why Shop on Desertcart? - 🛒 **Trusted by 1.3+ Million Shoppers** — Serving international shoppers since 2016 - 🌍 **Shop Globally** — Access 737+ million products across 21 categories - 💰 **No Hidden Fees** — All customs, duties, and taxes included in the price - 🔄 **15-Day Free Returns** — Hassle-free returns (30 days for PRO members) - 🔒 **Secure Payments** — Trusted payment options with buyer protection - ⭐ **TrustPilot Rated 4.5/5** — Based on 8,000+ happy customer reviews **Shop now:** [https://www.desertcart.tn/products/40959884-rules-and-guidance-for-pharmaceutical-manufacturers-and-distributors-2017-orange](https://www.desertcart.tn/products/40959884-rules-and-guidance-for-pharmaceutical-manufacturers-and-distributors-2017-orange) --- *Product available on Desertcart Tunisia* *Store origin: TN* *Last updated: 2026-08-17*