Ezi Mmepụta Ọgwụ (GMP) bụ iwu dị mkpa maka otu esi eme ọgwụ, site na ụlọ ọrụ na ndị ọrụ ruo na akwụkwọ na mwepụta otu. Na EU, onye ọ bụla na-emepụta ọgwụ chọrọ ikike nrụpụta ma ga-agbaso GMP, ebe maka ịchọ mma GMP dịkwa mkpa mana a na-eche na a ga-agbaso ụkpụrụ EN ISO 22716 kwekọrọ.
Na Netherlands, Ụlọ Ọrụ Nlekọta Ahụike na Ndị Ntorobịa (Inspectie Gezondheidszorg en Jeugd, IGJ) na-enyocha ndị na-emepụta ọgwụ ma na-enye asambodo GMP. Ihe ịchọ mma na-adaba n'okpuru usoro dị iche na onye nlekọta dị iche. N'okpuru ebe a, anyị na-akọwa ebe iwu GMP si bịa, ihe ha chọrọ, onye ga-aza ajụjụ na ihe na-eme mgbe onye nrụpụta anaghị agbaso iwu ahụ.
Gini bu GMP?
GMP is a quality assurance system that ensures products are consistently produced and controlled according to fixed standards, laid down for human medicines in Commission Directive (EU) 2017/1572. The idea is that quality cannot be tested into a product afterwards; it must be built into every step of production.
GMP therefore specifies how, and under which conditions, a medicine is made. All materials, intermediate products and the finished product are checked, and every step is recorded in the batch documentation. If a problem later appears in a batch, it must be possible to trace how it was made, who tested it and which materials were used.
GMP focuses on the typical risks of pharmaceutical production, such as cross-contamination (one product contaminated with components of another) and mix-ups caused by wrong labelling. It is part of the wider pharmaceutical quality system described in Chapter 1 of EudraLex Volume 4, which also covers product development, risk management and continuous improvement.
GMP dịkwa mkpa maka azụmaahịa mba ụwa. Ọtụtụ mba na-ekwe ka a bubata ma ree ọgwụ ndị e mepụtara dịka ụkpụrụ GMP a ma ama si dị. EU nwere nkwekọrịta nnabata nkeonwe na ọtụtụ mba, gụnyere United States, nke ndị ọchịchị na-adabere na nyocha GMP nke ibe ha.
Ebee ka iwu GMP si abịa?
GMP developed in the United States after a series of incidents with contaminated and unsafe medicines. The US Federal Food, Drug and Cosmetic Act of 1938 required proof of safety before a medicine could be marketed, and GMP requirements were added to US law in the 1960s. The World Health Organization later published international GMP guidelines.
United States
Companies that export medicines to the United States must comply with the current Good Manufacturing Practice (cGMP) rules of the Food and Drug Administration (FDA). These are set out in Title 21 of the Code of Federal Regulations, in particular Parts 210 and 211 for finished pharmaceuticals.
European Union
Na EU, iwu ndị bụ isi maka ọgwụ maka ojiji mmadụ dị na Ntuziaka 2001/83/EC. E depụtara ụkpụrụ GMP maka ọgwụ mmadụ na Ntuziaka Kọmitii (EU) 2017/1572, nke nọchiri Ntuziaka ochie nke 2003/94/EC. Maka ihe ndị na-arụ ọrụ, Iwu Ndị Kọmishọna (EU) Nke 1252/2014 na-emetụta. Maka ọgwụ anụmanụ, GMP na-esote ugbu a site na Iwu (EU) 2019/6 na ngwaahịa ọgwụ anụmanụ na iwu mmejuputa ya.
Ntuziaka zuru ezu dị na Mpịakọta nke 4 nke EudraLex , nchịkọta iwu EU gbasara ọgwụ. Ọ na-arụ ọrụ dị ka akwụkwọ ntuziaka bara uru maka itinye ụkpụrụ GMP n'ọrụ, yana isiakwụkwọ gbasara sistemụ mma, ndị ọrụ, ebe obibi na akụrụngwa, akwụkwọ, mmepụta, njikwa mma, ihe omume ndị a na-enye n'èzí, mkpesa na ncheta, na nyocha onwe onye, tinyere mgbakwunye maka ngwaahịa ụfọdụ dịka ọgwụ ndị na-adịghị ọcha. Ụlọ Ọrụ Ọgwụ nke Europe (EMA) na-ahazi nyocha na nyocha sayensị nke ọgwụ na EU.
Mba netherland
Na Netherlands, Iwu Ọgwụ (Geneesmiddelenwet) na-eme ihe ndị EU kwuru. Onye ọ bụla na-emepụta ọgwụ, gụnyere nkwakọ ngwaahịa na akara, chọrọ ikike nrụpụta (fabrikantenvergunning), ma ga-agbaso iwu GMP. A na-enye ikike ahụ n'aha Minista Ahụike, Ọdịmma na Egwuregwu mgbe IGJ nyochachara ya. Òtù Nyocha Ọgwụ (College ter Beoordeling van Geneesmiddelen, CBG) na-enyocha ngwa maka ikike ahịa.
Iwu ndị ọzọ nwere ike ịdị irè tinyere GMP. Ntuziaka Ọgwụ A Na-ajụ Agbanwe (2011/62/EU) na Iwu Enyere Aha (EU) 2016/161 chọrọ ihe nchọpụta pụrụ iche na ngwaọrụ mgbochi imebi ihe na ngwugwu nke ọtụtụ ọgwụ dọkịta nyere. Ihe ndị enwere ike iji mee ọgwụ (precursors) nwere iwu EU na Dutch dị iche, Iwu Opium (Opiumwet) na-emetụtakwa ihe ndị a na-achịkwa.
Gịnị ka GMP chọrọ n'ọrụ?
GMP chọrọ usoro mma ọgwụ edere ede nke na-ekpuchi ndị ọrụ, ebe obibi, akụrụngwa, ihe, mmepụta, njikwa mma na mkpesa. Onye nrụpụta ga-edozi ya, tinye ya ma mee ka ọ dị ọhụrụ, yana maka ọgwụ ndị e zubere naanị maka mbupụ.
N'omume, ihe ndị bụ isi achọrọ bụ ihe ndị a.
- Ndị ọrụ ruru eru, ndị a zụrụ azụ nwere ọrụ ndị a kọwara nke ọma, yana iwu ịdị ọcha, gụnyere ọrụ ịkọ ọrịa ma ọ bụ ọnyá mepere emepe nke nwere ike imetụta ngwaahịa ahụ
- Ebe obibi na akụrụngwa kwesịrị ekwesị, a na-ehicha ma na-edozi ya nke ọma
- Ihe ndị a kwadoro, akpa na akara, yana akara ziri ezi nke ihe ndị e ji arụ ọrụ, ngwaahịa etiti na nke emechara
- Ntuziaka ọrụ edere ede, nke akwadoro (usoro ọrụ ọkọlọtọ) n'asụsụ doro anya, yana ọzụzụ n'otú e si eji ha eme ihe
- Usoro nrụpụta akwadoro na ndekọ zuru oke nke na-egosi na emere usoro ọ bụla nke ọma
- Ndekọ na nyocha nke ihe ọ bụla gbagọrọ agbagọ site na ntuziaka ahụ
- Njikwa mma yana ụlọ nyocha na ngwa zuru oke, yana nchọcha zuru oke nke ogbe ọ bụla site na ihe eji arụ ọrụ ruo na onye ahịa
- Nchekwa na mbupu ziri ezi, usoro iji weghachite ogbe, na ijikwa mkpesa dị mma nke ọma
Ịdekọ ihe dị mkpa n'usoro a. Iwu dị mfe n'ime nyocha dị mfe: ọ bụrụ na e dekọghị ya, ọ meghị. A ga-ewere usoro e mere nke ọma mana edebeghị ya dị ka enweghị GMP.
Ònye bụ onye na-ahụ maka ọrụ n'ime ụlọ ọrụ ahụ?
GMP na-enye ndị ọrụ dị mkpa ọrụ pụrụ iche: onyeisi mmepụta ihe, onyeisi njikwa mma na onye ruru eru (QP). Ndị isi mmepụta na njikwa mma aghaghị ịnọ n'otu n'otu.
Onye ruru eru nwere ọkwa iwu pụrụ iche. Dịka Ntuziaka 2001/83/EC na Iwu Ọgwụ si dị, onye nrụpụta ọ bụla ga-enwerịrị opekata mpe otu QP n'aka ya ruo mgbe ebighị ebi. QP ga-akwado na emepụtara ma lelee ogbe ọ bụla dịka iwu na ikike ahịa si dị tupu ewepụta ya. Na-enweghị asambodo ahụ, a gaghị etinye ogbe ahụ n'ahịa. QP na-ebukwa ibu ọrụ nkeonwe, ọ bụ ya mere QP na-achọkarị nkọwa ederede doro anya nke ọrụ ha na ikike ịkwụsị ogbe.
How do you arrange outsourcing and quality agreements?
Mgbe ụlọ ọrụ na-enyefe ụlọ ọrụ ọzọ mmepụta ihe ma ọ bụ nnwale, GMP chọrọ nkwekọrịta ederede nke na-akọwa ọrụ nke onye ọ bụla. Isi nke 7 nke EudraLex Mpịakọta nke 4 na-akọwa ihe nkwekọrịta ịdị mma dị otú ahụ ga-ekpuchi.
Onye nyere nkwekọrịta ahụ ka na-ahụ maka ịdị mma nke ngwaahịa ya ma ga-enyocha ma onye nrụpụta nkwekọrịta ahụ ọ ruru eru. Nkwekọrịta ịdị mma ahụ na-akọwapụta, tinyere ihe ndị ọzọ, onye na-ewepụta otu, otu esi akọ akụkọ mgbanwe na mgbanwe, ma a na-ekwe ka e mee nkwekọrịta obere nkwekọrịta na otu esi eme nyocha. Site n'echiche iwu, ọ bụ ihe amamihe dị na ya ịhazi nkwekọrịta ịdị mma na nkwekọrịta ọkọnọ azụmaahịa. Esemokwu dị n'etiti ha abụọ, dịka ọmụmaatụ gbasara onye na-ebu ụgwọ nke iweghachite, na-apụta ìhè naanị mgbe a jụrụ otu otu.
Who supervises GMP and what happens if you do not comply?
Na Netherlands, IGJ na-enyocha ndị nrụpụta mgbe niile ma na-enye asambodo GMP ma ọ bụrụ na ha erube isi. Ọ bụrụ na onye nrụpụta emezughị ihe achọrọ, a pụrụ ịjụ ya asambodo GMP, a pụkwara ịkwụsị ma ọ bụ wepụ ikike nrụpụta ya.
IGJ na-enyochakwa ndị nrụpụta na-abụghị EU, dịka arịrịọ nke EMA ma ọ bụ CBG si dị. Mgbe onye nrụpụta a kpọtụrụ aha n'akwụkwọ ikike ahịa anaghị arụ ọrụ dịka GMP si dị, CBG nwere ike ikpebi, site na mkparịta ụka ya na IGJ na ndị ọchịchị Europe ndị ọzọ, iwepụ onye nrụpụta ahụ na akwụkwọ ikike ahụ. Ọ bụrụ na nke a nwere ike ibute ụkọ ọgwụ na Netherlands, onye nwere ikike ahịa ga-akọ ya na Ebe Nkwupụta Ọgwụ Mbelata na Mmebi (Meldpunt Geneesmiddelentekorten en -defecten).
IGJ nwekwara ike itinye usoro nchịkwa, dịka iwu nke a ga-akwụ ụgwọ ntaramahụhụ (ikpeazụ onder dwangsom) ma ọ bụ ntaramahụhụ nchịkwa (bestuurlijke boete) n'okpuru Iwu Ọgwụ. Maka mkpebi ndị dị otú ahụ, ị nwere ike itinye akwụkwọ mkpesa (bezwaar) n'aka ndị ọchịchị wee tinye akwụkwọ mkpesa na ụlọikpe nchịkwa. Oge njedebe maka mkpesa bụ izu isii site na ụbọchị ezitere mkpebi ahụ (Nkebi nke 6:7 nke Iwu Iwu Nchịkwa Izugbe, Awb).
Ọdịda GMP nwekwara ike ibute nsogbu obodo. Onye zụrụ ma ọ bụ onye nwere ikike nwere ike ịta onye nrụpụta ụta maka mmebi nkwekọrịta, onye na-emepụta ngwaahịa nwere nkwarụ ga-ana ndị merụrụ ahụ ụgwọ n'okpuru iwu ibu ọrụ ngwaahịa dị na Isiokwu 6:185 ruo 6:193 BW. Maka mkpesa maka mmerụ ahụ ahụ, anyị na-eziga ndị ahịa na ọkachamara mmerụ ahụ nkeonwe.
GMP ọ na-emetụtakwa ihe ịchọ mma?
Ee. Dịka Iwu nke 8 nke Iwu Nhazi Ihe Ọcha nke EU (EC) Nke 1223/2009 si dị, a ga-emepụta ngwaahịa ịchọ mma dịka GMP si dị. A na-eche na a ga-eme ya mgbe mmepụta ahụ na-agbaso ọkọlọtọ kwekọrọ, nke bụ EN ISO 22716:2007.
ISO 22716 contains guidelines for the production, control, storage and shipment of cosmetic products. It covers personnel, premises, equipment, raw materials, production, quality control, deviations, complaints, recalls and internal audits. The standard itself states that it does not cover research and development, the distribution of finished products, the safety of personnel or the protection of the environment.
Iji ọkọlọtọ ahụ eme ihe bụ afọ ofufo, mana ọ bụ ụzọ kachasị mfe iji gosi na ọ na-agbaso iwu. Onye nrụpụta nke na-eji ụzọ ọzọ ga-enwerịrị ike igosi na ọ na-enweta otu ọkwa nke ịdị mma na nchekwa.
Na Netherlands, Iwu Iwu Ngwaahịa na ngwaahịa ịchọ mma (Warenwetbesluit cosmetische producten) na-agbakwụnye Iwu Nhazi Mma. Nlekọta nke ihe ịchọ mma dị n'aka Netherlands Food and Consumer Product Safety Authority (NVWA), ọ bụghị na IGJ. Onye nwere ọrụ nke na-etinye ngwaahịa ịchọ mma n'ahịa EU ga-edebe faịlụ ozi ngwaahịa nke gụnyere nkọwa nke ụzọ e si emepụta ihe na nkwupụta nke nrubeisi na GMP (Isiokwu nke 11 nke Iwu Nhazi Mma).
What should you check as a contract giver?
When you outsource manufacturing or testing, you remain responsible for the quality of your product under Chapter 7 of EudraLex Volume 4. Check at least the following:
- That the contract manufacturer holds a valid manufacturing licence and a current GMP certificate, for example in the EudraGMDP database.
- That a written quality agreement sets out who releases batches and which Qualified Person certifies them.
- That you have a right to audit the site and to be informed of deviations and changes.
- That subcontracting is excluded or requires your prior written consent.
- That the supply agreement and the quality agreement say the same about recall costs and liability.
What should you check as a contract manufacturer?
As contract acceptor you must meet GMP for every activity you perform, and the IGJ inspects you directly. Check these points before you sign:
- That your manufacturing licence covers the dosage forms and activities in the contract.
- That the quality agreement does not shift responsibilities to you that belong to the marketing authorisation holder.
- That your liability for a rejected or recalled batch is capped in the supply agreement.
- That your QP has written authority to stop a batch, whatever the commercial pressure.
- That deviations, complaints and changes are reported to the contract giver within agreed deadlines.
What can we do for you with GMP?
We advise manufacturers, contract manufacturers and distributors on pharmaceutical and cosmetics law; more about this work is on our ụlọ ọrụ ọka iwu page.
- We draft and review quality agreements in line with Chapter 7 of EudraLex Volume 4.
- We align quality agreements with supply agreements, including recall costs and liability caps.
- We draft the objection against an IGJ fine or order subject to a penalty and file it within the six-week deadline.
- We review the legal position of your Qualified Person and draft a clear task description.
- We assess the product information file and GMP statement for a cosmetic product before it goes on the market.
Summary
- GMP bụ usoro mma iwu kwadoro maka imepụta ọgwụ, nke dabere na EU na Ntuziaka 2001/83/EC, Ntuziaka (EU) 2017/1572 na EudraLex Mpịakọta 4.
- Na Netherlands, ndị nrụpụta chọrọ ikike nrụpụta dịka Iwu Ọgwụ si dị; IGJ na-enyocha ma na-enye asambodo GMP.
- Onye ruru eru ga-enwerịrị asambodo nke ọ bụla tupu ewepụta ya.
- Mgbe ị na-enye ọrụ n'èzí, nkwekọrịta ịdị mma edere ede dị mkpa; mee ka ọ dabara na nkwekọrịta azụmahịa gị.
- Maka ihe ịchọ mma, a chọrọ GMP dịka Iwu nke 8 nke Iwu (EC) Nke 1223/2009 si dị, a na-echekwa na a ga-agbaso iwu EN ISO 22716; NVWA na-ahụ maka ya.
Ọtụtụ mgbe Ẹbụp Ajụjụ
Asambodo GMP ọ bụ otu ihe ahụ dị ka ikike nrụpụta?
No. The manufacturing licence under the Medicines Act is the permission to manufacture medicines. The GMP certificate confirms that an IGJ inspection found the manufacturer to comply with GMP. Without GMP compliance, you will not obtain or keep a licence.
Ònye na-enyocha nrubeisi GMP na Netherlands?
For medicines, the Health and Youth Care Inspectorate (IGJ). It inspects manufacturers in the Netherlands and, at the request of the EMA or the CBG, also outside the EU. For cosmetics, the Netherlands Food and Consumer Product Safety Authority (NVWA) is the supervisory authority.
Enwere m ike ịjụ ihe IGJ mere?
Yes. Against a decision such as an administrative fine or an order subject to a penalty payment, you can lodge an objection within six weeks (Article 6:7 Awb). After the decision on the objection, you can appeal to the administrative court.
Does ISO 22716 certification make a cosmetic product compliant?
Following EN ISO 22716 creates a presumption that the manufacture complies with GMP under Article 8 of Regulation (EC) No 1223/2009. The product must still meet the other requirements of the Regulation, including the product information file under Article 11.
