WHO GMP Certificate Kya Hai? Process & Benefits
Socho aap medical store se ek dawai khareedte hain. Aapko kaise pata chalega ki wo dawai saaf jagah par, sahi tareeke se aur sahi quality ke saath banayi gayi hai? Aap to factory ke andar jhaank nahi sakte. Yahi sabse bada sawaal har patient, har pharmacist aur har dukandaar ke man me aata hai — “is dawai par bharosa karoon ya nahi?”
Iss bharose ka jawab ek certificate me chhupa hota hai, jiska naam hai WHO GMP certificate. Agar aap janna chahte hain ki who gmp certificate kya hai, ye kaise banta hai, kaun deta hai aur aam aadmi ke liye iska kya matlab hai — to ye article aapke saare sawaalon ka jawab simple Hindi me dega. Koi technical jaal nahi, sirf seedhi aur kaam ki baat.
WHO GMP Certificate Kya Hai? (Seedha Aur Saaf Jawab)
WHO GMP certificate ek aisa pramaan-patra (certificate) hai jo ye saabit karta hai ki kisi dawai banane wali factory ne World Health Organization (WHO) ke “Good Manufacturing Practices” niyamon ka palan kiya hai. Aasaan shabdon me — ye is baat ki guarantee hai ki dawai ek safe, saaf aur control wale tareeke se banayi gayi hai, jisme quality har step par check ki gayi hai.
Yahaan “GMP” ka matlab hai Good Manufacturing Practices yaani “achhi nirmaan prakriyaayein”. WHO duniya ki sabse badi swasthya sanstha hai, aur uske banaye gaye GMP standards ko duniya bhar me bharose ka paimana maana jaata hai. Jab koi factory in standards par khari utarti hai, to use WHO GMP certificate diya jaata hai.
Bharat me ye certificate CDSCO (Central Drugs Standard Control Organisation) aur rajya ke State Licensing Authority dwara, WHO ke format me jaari kiya jaata hai.
Ek line me yaad rakhein: WHO GMP certificate = dawai ki quality aur safety ka official saboot.
WHO GMP Ka Full Form Aur Matlab
Chaliye iske naam ko todkar samajhte hain:
- W – World
- H – Health
- O – Organization
- G – Good
- M – Manufacturing
- P – Practices
To poora matlab hua: World Health Organization – Good Manufacturing Practices. Yaani WHO dwara nirdharit “achhi dawai banane ki vidhi” ka palan karna.
WHO ke anusaar, GMP ek aisa system hai jo ye sunishchit karta hai ki product har baar ek jaisi quality ke saath bane. Sirf final dawai ko test karna kaafi nahi hota — kyunki kuch galtiyan test me pakad me nahi aatin. Isliye GMP poori manufacturing prakriya par dhyaan deta hai, shuruaat se lekar packaging tak.
GMP Aur WHO-GMP Me Kya Antar Hai?
Bahut log in dono ko ek hi samajh lete hain, lekin halka sa farq hai:
- GMP ek aam shabd hai jo har desh ke apne manufacturing niyamon ke liye use hota hai.
- WHO-GMP specifically WHO ke antarrashtriya (international) standards ko follow karta hai, jo global level par maanya hote hain.
Bharat me GMP ke niyam Schedule M ke andar diye gaye hain (jiske baare me hum aage detail me baat karenge). Jab koi factory in niyamon ke saath-saath WHO ke standards bhi follow karti hai, to use WHO-GMP certificate milta hai — jo videsh (export) ke liye bahut zaroori hota hai.
WHO GMP Certificate Kyun Zaroori Hai?
Ye sirf ek kaagaz ka tukda nahi, balki bharose ki muhar hai. Aaiye samajhte hain ki ye itna mahatvapurna kyun hai.
1. Patient Ki Suraksha Sabse Pehle
Galat tareeke se banayi gayi dawai jaan le sakti hai. Haal hi me Bharat me dushit (contaminated) cough syrup se bachon ki mauton ne poori industry ko hila diya tha. WHO GMP iss tarah ki galtiyon ko rokne ke liye banaya gaya hai.
2. Quality Ki Guarantee
Ye certificate batata hai ki dawai ke raw material se lekar final packaging tak, har step quality control se gujra hai.
3. Export Ke Liye Anivaarya
Duniya ke 80 se zyada desh sirf un dawaiyon ko apne yahan aane dete hain jinke paas WHO GMP ya COPP certificate ho. Bina iske bharat se dawai export karna lagbhag namumkin hai.
4. Brand Aur Bharosa
WHO GMP certified company ka naam market me zyada bharose ke saath liya jaata hai. Doctors, distributors aur patients sabhi aisi company ko prathmikta dete hain.
WHO GMP Certificate Ke Fayde (Benefits)
Yahaan ek nazar me iske mukhya fayde dekhiye:
- Antarrashtriya bazaar tak pahunch — videsh me dawai bechne ka raasta khulta hai.
- Customer ka bharosa — quality saabit hone par bikri badhti hai.
- Kanooni suraksha — government niyamon ka palan hone se penalty aur factory band hone ka khatra kam hota hai.
- Kam product rejection aur recall — quality pehle se check hone par dawai wapas mangwane ki nautab nahi aati.
- Pratispardha me aage — competitors ke muqable behtar position.
- Behtar internal system — factory ke andar har kaam organize aur documented ho jaata hai.
WHO GMP Certificate Kaise Milta Hai? (Step-by-Step Process)
Ab sabse important sawaal — process kya hai? Bharat me ye prakriya ab poori tarah online ho chuki hai. 15 July 2025 se, WHO-GMP aur COPP ke saare applications sirf ONDLS portal (Online National Drugs Licensing System) ke through hi accept kiye jaate hain. Physical file ab nahi chalti.
Niche poora process simple steps me samjha gaya hai:
Step 1: Eligibility Check Aur License
Sabse pehle, applicant ke paas ek valid drug manufacturing license (State FDA ya CDSCO se) hona zaroori hai. Bina manufacturing license ke WHO GMP certificate nahi milta.
Step 2: ONDLS Portal Par Registration
ONDLS portal par mobile number aur OTP ke through login/register karein. Apni purani license details “Old License Management” section me submit karein.
Step 3: Documents Taiyar Karein
Application se pehle saare zaroori documents (jinki list aage di gayi hai) scan karke taiyar rakhein.
Step 4: Online Application Submit Karein
Manufacturer Dashboard se “Application Processing” → “Fresh Application Submission” par jaakar “Issue of Certificate” select karein. Phir WHO-GMP ya COPP form chunein aur firm ki saari details bharein.
Step 5: Fees Bhugtan
Online portal par nirdharit shulk (fees) jama karein. COPP ke liye har country copy par alag fees lagti hai.
Step 6: Factory Ki Inspection (Audit)
Application milne ke baad, State Licensing Authority aur CDSCO ki team milkar factory ka joint inspection karti hai. Inspector machine, hygiene, documents, SOP aur staff training — sab kuch jaanchte hain.
Step 7: Kamiyon (Observations) Ka Sudhaar
Agar koi kami milti hai to use “observation” likha jaata hai. Badi kamiyon ko theek karne ke baad hi certificate milta hai.
Step 8: Certificate Jaari
Sab kuch sahi paaye jaane par, WHO-GMP certificate (ya COPP) WHO ke format me jaari kar diya jaata hai.
Note: Saari prakriya me factory ki ready-state sabse important hai. Agar site inspection ke liye taiyar nahi hai, to application reject ho sakti hai.
WHO GMP Ke Liye Zaroori Documents
Application ke samay aam taur par ye documents lagte hain:
- Valid manufacturing license ki copy
- Site Master File (factory ka poora layout aur details)
- Factory ka layout plan with dimensions aur cleanroom specifications
- Production, cleaning, packaging aur QC ke SOPs
- Pichhle 3 product batches ke records aur stability test reports
- Staff ke training records
- Applicant ki pehchaan ke documents (PAN, Aadhaar etc.)
- Product summary sheet
Revised Schedule M Aur WHO GMP Ka Connection (2025–2026 Update)
Ye sabse latest aur zaroori jankari hai jo har manufacturer ko pata honi chahiye.
Schedule M, Drugs & Cosmetics Act 1940 ka wo hissa hai jisme bharat me dawai banane ke GMP niyam diye gaye hain. 28 December 2023 ko Bharat sarkar ne Revised Schedule M notify kiya, jo purane niyamon se kahin zyada sakht hai aur WHO-GMP ke kareeb le aaya gaya hai.
Iske deadlines kuch is tarah rahe:
- Badi companies (turnover ₹250 crore se zyada): 2024 ke madhya tak compliance zaroori tha.
- Chhoti aur madhyam companies (turnover ₹250 crore ya kam): Deadline badhakar 31 December 2025 ki gayi, lekin sirf un MSME units ke liye jinhone samay par Form A me apna upgrade plan submit kiya.
1 January 2026 se, CDSCO ne saaf kar diya hai ki Revised Schedule M ab sabhi manufacturers par laagu hai, aur state regulators ko inspection shuru karne ke nirdesh diye gaye hain. Cough syrup se hui bachon ki mauton ke baad sarkar ne is mamle me koi dheel nahi di. Yaani ab Schedule M compliance sirf ek vikalp nahi, balki anivaarya zaroorat ban chuki hai.
Iska seedha matlab — agar koi factory aaj WHO GMP standards follow nahi karti, to uske license par khatra hai.
(Sandarbh ke liye: PIB Notification aur CDSCO ki official websites par poori jankari uplabdh hai.)
COPP Aur WHO GMP Certificate Me Antar
Ye do shabd aksar saath me sunai dete hain, isliye confusion hota hai:
- WHO GMP Certificate — factory ke level par diya jaata hai. Ye batata hai ki factory WHO standards par dawai banati hai.
- COPP (Certificate of Pharmaceutical Product) — kisi specific product ke liye diya jaata hai. Ye batata hai ki wo dawai uss desh me bechne ke liye approved hai aur GMP-certified factory me bani hai.
Aasaan shabdon me — WHO GMP poori factory ke liye, aur COPP ek-ek dawai ke export ke liye. COPP Bharat me CDSCO dwara DCGI ke under jaari hota hai aur 80+ deshon me export ke liye maanya hai.
WHO GMP Certificate Ki Validity Aur Renewal
WHO GMP certificate hamesha ke liye nahi hota. Ye aam taur par kuch saal (zyadatar 3 saal tak) ke liye valid hota hai, jiske baad ise renew karwana padta hai. Renewal ke samay phir se inspection ho sakti hai, taaki ye pakka kiya ja sake ki factory abhi bhi standards par khari utar rahi hai. Iske alawa, samay-samay par audits bhi hote rehte hain.
Isliye certified rehna ek baar ka kaam nahi — ye ek lagataar (ongoing) zimmedari hai.
WHO GMP Certificate Ki Cost Kitni Hoti Hai?
Cost ek fixed number nahi hoti, ye kai baaton par nirbhar karti hai:
- Factory ka size aur current condition
- Upgrade aur renovation me kitna kharcha lagega
- Documentation aur consultant ki fees
- Government fees (jaise COPP par per-country copy fees)
Chhoti factory ke liye kharcha kam ho sakta hai, jabki Revised Schedule M ke hisaab se poori factory upgrade karne par lakhon-crores tak ka kharcha aa sakta hai. Isliye sahi planning aur ek anubhavi consultant ki salah zaroori hoti hai.
Kaun Apply Kar Sakta Hai Aur Kise Zaroorat Hai?
WHO GMP certificate ki zaroorat hai:
- Dawai banane wali pharmaceutical companies ko
- Wo manufacturers jo videsh me dawai export karna chahte hain
- Wo companies jo bade hospitals, government tenders ya antarrashtriya buyers ke saath kaam karti hain
- Cosmetic aur medical device banane wale (kuch cases me)
Kise turant dhyaan dena chahiye:
- Aisi koi bhi factory jo abhi tak Revised Schedule M ke hisaab se update nahi hui hai — kyunki ab inspections shuru ho chuke hain.
Aam Galtiyan (Common Mistakes) Jinse Bachna Chahiye
Anubhav ke aadhaar par, ye galtiyan sabse zyada nuksan karti hain:
- Documentation adhuri rakhna — SOPs aur batch records sahi na hone par application reject ho jaati hai.
- Inspection se pehle site ready na hona — adhuri taiyari par fees bhi doob sakti hai.
- Staff training ko ignore karna — inspector staff se sawaal poochte hain.
- Deadline ko last moment tak taalna — Schedule M upgrade me time aur paisa dono lagta hai.
- Online process ko galat samajhna — ab sirf ONDLS portal hi maanya hai, isliye sahi platform par hi apply karein.
Expert Tips: Smooth Approval Ke Liye
- Pehle gap analysis karwayein — apni factory ki kamiyon ko inspector se pehle khud pakdein.
- Mock audit karwayein taaki real inspection me surprise na ho.
- Digital record-keeping apnayein — Revised Schedule M checklist nahi, system maangta hai.
- Quality ko documentation tak seemit mat rakhein — usse rozana practice me laayein.
- Anubhavi consultant ya regulatory expert ki salah lein, khaaskar chhoti MSME units.
Aam Aadmi Ke Liye WHO GMP Ka Kya Matlab Hai?
Agar aap manufacturer nahi, balki ek patient, pharmacy student ya medical store maalik hain, to ye section aapke liye hai.
WHO GMP certified factory me bani dawai par bharosa karna zyada surakshit hota hai. Aap medicine ki packaging, company ki website ya distributor se ye jankari le sakte hain ki dawai kisi GMP-certified facility me bani hai ya nahi. Acchi companies isse apni shaan se dikhati hain.
Yaad rakhein — sasti dawai hamesha achhi nahi hoti, aur mehngi dawai hamesha surakshit nahi hoti. Asli farak banata hai quality system, jiska saboot WHO GMP certificate hai.
Frequently Asked Questions (FAQs)
Q1. WHO GMP certificate kya hai?
WHO GMP certificate ek pramaan-patra hai jo saabit karta hai ki dawai banane wali factory ne WHO ke Good Manufacturing Practices niyamon ka palan kiya hai. Ye dawai ki quality aur safety ki guarantee deta hai.
Q2. WHO GMP ka full form kya hai?
WHO GMP ka full form hai World Health Organization – Good Manufacturing Practices.
Q3. Bharat me WHO GMP certificate kaun deta hai?
Bharat me ye certificate CDSCO (Central Drugs Standard Control Organisation) aur State Licensing Authority dwara, WHO ke format me jaari kiya jaata hai.
Q4. WHO GMP certificate kaise apply karein?
15 July 2025 se ye prakriya poori tarah online hai. Aapko ONDLS portal (statedrugs.gov.in) par application submit karni hoti hai, jiske baad factory ki inspection hoti hai aur sab sahi hone par certificate milta hai.
Q5. WHO GMP aur GMP me kya antar hai?
GMP aam manufacturing niyam hai, jabki WHO-GMP WHO ke antarrashtriya standards follow karta hai jo global aur export ke liye maanya hote hain.
Q6. WHO GMP certificate ki validity kitni hoti hai?
Ye aam taur par kuch saal (zyadatar 3 saal tak) ke liye valid hota hai, jiske baad renewal aur dobara inspection ho sakti hai.
Q7. COPP aur WHO GMP certificate me kya farak hai?
WHO GMP poori factory ke liye hota hai, jabki COPP kisi specific product ke export ke liye jaari kiya jaata hai.
Q8. Kya WHO GMP certificate har dawai company ke liye zaroori hai?
Export aur quality compliance ke liye ye lagbhag anivaarya hai. Saath hi, Revised Schedule M ke karan ab sabhi manufacturers ke liye GMP standards 1 January 2026 se laagu ho chuke hain.
Q9. WHO GMP certificate ki cost kitni hoti hai?
Cost factory ke size, upgrade aur documentation par nirbhar karti hai. Chhoti units ke liye kam, badi factory ke liye lakhon-crores tak ho sakti hai.
Q10. Revised Schedule M kya hai aur ye WHO GMP se kaise juda hai?
Revised Schedule M Bharat ka sakht GMP niyam hai jo WHO standards ke kareeb hai. 2023 me notify hua aur 1 January 2026 se sabhi manufacturers par laagu hai.
Nishkarsh (Conclusion)
To ab aap acche se samajh gaye honge ki who gmp certificate kya hai aur ye kyun itna mahatvapurna hai. Ye sirf ek certificate nahi, balki har dawai ke peeche chhupe bharose ka asli saboot hai. Chahe aap ek manufacturer hon jo apni factory ko certified karna chahta hai, ya ek aam aadmi jo surakshit dawai chahta hai — WHO GMP ka matlab samajhna aapke liye faydemand hai.
Bharat me Revised Schedule M ke aane ke baad, ab quality ke saath koi samjhauta nahi ho sakta. Aur yahi badlav Bharat ko duniya ki sabse bharosemand “pharmacy of the world” banane ki disha me le ja raha hai.
Agar aapko dawaiyon, unki quality aur pharma industry se judi aisi hi aasan jankari chahiye, to The Pharma Project ke saath jude rahiye.