Good Distribution Practice for Medicines

GMP covers how a medicine is made and checked until a Qualified Person certifies each batch. GDP takes over from there and keeps the certified product's quality intact as it is stored, transported and traded down to the pharmacy. In EU law they are separate obligations: they attach to different authorisations, rest on different articles of Directive 2001/83/EC, have different named responsible people, and come with separate Commission guidelines.

Approach: I read the current consolidated Directive 2001/83/EC and EudraLex Volume 4 (the EU GMP Guide), and took the GDP side from the Directive provisions and 2013 GDP Guidelines covered in my previous answer. This covers EU human medicines only.

Side-by-side

	GMP	GDP
Definition	"that part of Quality Management which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorisation, Clinical Trial Authorisation or product specification"; it "is concerned with both production and quality control" (GMP Guide, Ch. 1, 1.8) [8]	The part of quality assurance that keeps quality intact across the supply chain, from the manufacturing site to the pharmacy or other person entitled to supply the public (2013 GDP Guidelines glossary)
Who it binds	Holders of a manufacturing authorisation, which is required to manufacture "even if the products are for export" (Art. 40(1)) [9]	Holders of a wholesale distribution authorisation (Art. 77), and brokers [2][5]
Core legal duty	Art. 46(f): "to comply with the principles and guidelines of good manufacturing practice" [10]	Art. 80(g): comply with GDP [4]
How the rules are set	The Commission adopts the GMP principles and guidelines by delegated acts. It then publishes detailed guidelines (Art. 47), which is EudraLex Volume 4 [11]	"The Commission shall publish guidelines on good distribution practice" (Art. 84) [3]; this is Guidelines 2013/C 343/01
Key person	Qualified Person (QP), who must be available "permanently and continuously" (Art. 48) [12]	Responsible Person (RP), designated under Ch. 2 of the GDP Guidelines
What that person signs off	Certifies in a register that each production batch complies, before release for sale; the register is kept for at least five years (Art. 51(3)) [13]	Approves suppliers and customers, runs recalls, decides what happens to returned, rejected or falsified stock
Technical focus	Validated processes, qualified premises and equipment, quality control testing, batch records, investigating deviations (1.8, 1.9) [8][14]	Buying from and selling to authorised parties only, storage and transport conditions, records of each transaction, checking safety features, emergency recall plan

Where the two meet

• The handover point is QP certification. The pharmaceutical quality system must ensure products "are not sold or supplied before a Qualified Person has certified that each production batch" meets the marketing authorisation (1.4(xv)) ^[15]. GDP governs what happens to the batch after that.
• GMP already looks downstream. One of GMP's basic requirements is that "the distribution of the products minimises any risk to their quality and takes account of Good Distribution Practice". GMP also requires distribution records that let the full history of a batch be traced, and a recall system (1.8(viii)-(x)) ^[8]. The quality system must ensure products are "stored, distributed and subsequently handled so that quality is maintained throughout their shelf life" (1.4(xvi)) ^[15].
• One licence can cover both activities. A manufacturing authorisation also covers wholesale distribution of the products it covers (Art. 77) ^[2]. As noted last time, manufacturers distributing their own products must still comply with GDP.
• Active substances have their own GMP and GDP. The manufacturing authorisation holder "shall" use only active substances made under GMP for active substances and distributed under GDP for active substances. It must check this by auditing the sites of the manufacturers and distributors (Art. 46(f)) ^[10]. Under Art. 47, GDP for active substances is adopted as Commission guidelines ^[11]. The GMP Guide repeats the audit requirement (Ch. 5, 5.29) ^[16], and it is one of the points the QP confirms before certifying a batch (Annex 16, 1.7.7) ^[17].
• Inspection and certificates go into one EU database. Both regimes are inspected, and GMP and GDP certificates are recorded in EudraGMDP, the database under Article 111(6) of Directive 2001/83/EC ^[18]. EMA's abbreviation list uses "GMDP" for the two together ^[18].

I can set out the US equivalent next if useful: FDA cGMP under 21 CFR Parts 210/211, set against US distribution controls.

In the EU, GDP training covers people and a GDP certificate covers organisations. The 2013 GDP Guidelines say everyone involved in wholesale distribution, the Responsible Person and broker staff "should" be trained in GDP. A GDP certificate is issued by the national competent authority to an inspected entity whose inspection shows it complies. Nobody applies for one as a separate licence, and neither text I read requires individuals to hold a personal GDP certificate. What they require is that training is recorded.

Approach: I read the current consolidated Directive 2001/83/EC and the Commission's GDP Guidelines of 5 November 2013 (2013/C 343/01). This covers EU human medicines only. I did not open the separate GDP guidelines for active substances, the veterinary rules, or national rules on what qualifications a Responsible Person needs.

Who needs GDP training (2013 Guidelines)

Who	What the Guidelines say
All personnel involved in wholesale distribution (Ch. 2.4)	"should be trained on the requirements of GDP" and have the right competence and experience "prior to commencing their tasks". Training is initial and continuing, relevant to the role, and follows written procedures and a written training programme. It "should include" product identification and keeping falsified medicines out of the supply chain.
Responsible Person (Ch. 2.2, 2.4)	"should have appropriate competence and experience as well as knowledge of and training in GDP", and should keep up that competence "through regular training". The RP also has to make sure initial and continuing training programmes are put in place and kept running.
Staff handling products that need stricter handling (Ch. 2.4)	"should receive specific training". The examples given are hazardous products, radioactive materials, narcotics and psychotropics, and temperature-sensitive products.
Staff packing insulated boxes for cold-chain shipments (Ch. 9.4)	"Staff must be trained" on how to assemble the boxes (seasonal configurations) and on reusing cool-packs. This is the only training duty in the Guidelines worded with "must".
Broker personnel (Ch. 10.3)	Anyone involved in brokering "should be trained in the applicable EU and national legislation and in the issues concerning falsified medicinal products".
Manufacturers distributing their own products (Introduction)	"must therefore comply with GDP", including the personnel chapter. Other actors in distribution "should" follow the relevant sections.

Evidence of training: "A record of all training should be kept", and the effectiveness of the training "should be periodically assessed and documented" (Ch. 2.4). The Directive itself only requires staff, "in particular, a qualified person designated as responsible", who meet the conditions set by the Member State's own law (Art. 79(b)) ^[19].

Who gets a GDP certificate (Directive 2001/83/EC)

• How a certificate is issued: within 90 days of an inspection, a GMP or GDP certificate "shall, when applicable, be issued to the inspected entity" if the inspection shows compliance (Art. 111(5)). Member States enter the certificates in the public Union database run by EMA (Art. 111(6)) ^[7]. The form and content of the certificate are set by the Member States together with EMA (Art. 111a) ^[20].
• Who is inspected:
  • Wholesale distributors: "shall be subject to repeated inspections" (Art. 111(1a)). They also need a wholesale distribution authorisation for each of their premises (Art. 77(1)) ^[6][2].
  • Distributors of active substances: EU-based importers, manufacturers and distributors of active substances are supervised through inspections "at an appropriate frequency based on risk" (Art. 111(1b)). They "shall register" their activity at least 60 days before they start (Art. 52a(1), (3)). That registration also goes into the Union database (Art. 52a(7)) ^[6][21].
  • Brokers: they "may" be inspected (Art. 111(1d)), under the responsibility of the Member State where they are registered (Art. 85b(4)). Their legal basis is registration, not an authorisation (Art. 85b(2)) ^[6][5]. The Directive does not say whether a broker inspection leads to a GDP certificate. It only says certificates are issued "when applicable".
• If the inspection finds non-compliance: for distributors of medicines or active substances, that finding is entered in the same Union database instead of a certificate (Art. 111(7)) ^[7].
• Buyers check their suppliers: a wholesaler buying from another wholesaler "must verify" that supplier's GDP compliance and authorisation (Art. 80) ^[4]. In practice the certificate in the Union database is one way to do this check.

The short version: pharmacies supplying the public fall outside wholesale distribution. But if national law lets them also trade wholesale, they "shall" hold a wholesale authorisation (Art. 77(2)) ^[2], and that brings in the full GDP duties, including staff training and inspection.

I can cover the UK approach next (MHRA WDA(H) licensing and Responsible Person eligibility) if you need it.