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Goederenon:Nangstbon 18. juli 2018
ivdek01
Pharma Greven GmbHThomas NadlerHuttruper Heide 90D-48268 GrevenGermany
Orderleveranciersnr. 2420
Brondocument lnkooporder
Bronnr. BM 80822
Expediteur
Opslagnummer OPS-027946B
Uw referentie
Orderdatum 28-05-18
Verkoper/Inkoper Lisette Jonker- Bosma
Nr. ONT~027832B
Regelnr. 10000
Ar r. Omschrijving
500511 Nystatinum
(124990)
Aantal
96,708
Vestiging BU 01 Laboratoriumcode
Zone IKG Bewaarconditiecode
Opslaglocatie >Otte Magazijnklasse
Werkzame stof
Aard beschadiging GEEN Monstergrootte
Beoordeling verpakking GOED Monstereenheid
Gevaaraanduiding Artikelkeurgroepcode
GevaaraanduidIng 2 Verhoogd risico
Intern artikelnr. 100827-114-91
Producent lotnr. Chargenr.
401 0236
lrzorgsmaatregelen
L•abine afplakken; gekleurde grondstof !!
Autom. tekstuitbreidingsregels
6x100 BOU = 16,118 Kg / 100 BOU
ex Antibiotce S.A.
600 bou = +I- 96,708 kg
Inkoopordertextregels
BATCH: 401 0236 EXP:5-2021
1 bou = € 34,657
Would you be so kind to confirm this order by mail
IMPORTANT NOTE!!!
Aanvullende keuringsinstructies
.--4PARENTERAALL alle eenheden OPId. testen
r ( 4REG-MICRO .waarde bepaling: minimaal extra 20 gram nodig •
Abnormale toxiciteit:copy AC producentn
11:1 7 ..7t-Id.monsters:alleen IR is voldoende
Gehalte eis NLT 5000 !
Fermentatie statment aanwezig van de fabrikant Antibiotice.
14F05-1301:Composition dp,nog ter evaluatie:volgende charge weer?(getolereerde deelkeuring?)
Miv 14J09-001 "getolereerde deelkeuring" op composition.
15G23-B02:00T gehalte probleem bij Eurofins. lnitiele resultaat "invalid" verklaard.Nieuwe charge wer evalueren(controleer recovery!)
16016-B05:weer OOT gehalte probleem, risicoanalyse:acceptabel. Volgende charge weer evaluerenidem probleem 16G21-009
Fagron Services B.V.Molenwerf 131911 DB UITGEEST
GerealiseerdeEenheidsco Vervaldat Week ontvangstdatum
KG 19-07-18 29 18-07-18
PROXYLAB Fabrikantnr.
KOELTRANSP
1
Ja
30 2 )
VOLL
Nee
Vervaldatum Keurstatus
2466
Antibiotice S.A.
Valea Lupului nr.1
707410 LASI
RO
18G18-001 31-05-21 Nieuw
fDatum: i•Paraaf:
'ATTENTlE• revised text Ph. Eur. 9.0
Gehalte 'dried en 'as is' laten rapporteren door het lab en beide vermelden op ons CoA.
Datum:
Paraaf:
PRODUCT NAME
PRODUCER :
TEXT DATA ON EXTERNAL BULK CONTAINERS
SUPPLIER :
• •••:,
MANUFACTURING DATE : EXPIRY DATE :
REMARKS (E.G. STORAGE CONDITION / QUALITY STANDARD / STERILITY) :
/24 ,42v, s:
INSPECTION
SORT CONTAINER: B - i, ik,,,_ , . KG/GR/L-Tit
NUMBER OF CONTAINERS :
EACH CONTAINER SHOWS PRODUCT NAME ?
GRAMS/KGSAFFERS = • , ,' _ TOTAL,
El YES • NOEACH CONTAINER SHOWS BATCH NUMBER ? 0 YES El NO —COMPLETE BATCH 1 UNIQUE LOT NUMBER ? N. YES • NO . . ..
COMPLETE BATCH SEALED ? gi YES • NONAME EMPLOYEE + DATE : - ,
1 INSPECTION PACKAGING MATERIAL
INSPECTION PROCEDURE ACCORDING TO PROCEDURE NUMBER P41.3.5
INSPECTION LABEL
INITIALS/DATE
, ,
Appearance(form;colour;dimension)Eagreed • not agreedAbsence damages • agreed El not agreed
Closure (cap;lid) El agreed E not agreed
Number of units analyzed ... ... ... ... ........
SAMPLING
CONTROL PRODUCER LOTNR / INTERNAL LABELS FSNL_
PARAAF/DATUM: . _..
dNUMBER X UNIT FAGRON
- , X /ML/PACK.,,....-- Monster
, X1GR/ML/PACK. ' -
., 1.1-.,„rs t a t i n um
X_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ .,.)
GR/ML/PACK.
: s.,-, PH . EUR .
,INITIALS/DATE. ‘
Batch No. : Artik..1nr . : Volqnr. :18G18-B01 500511/12,1990 M01.2
RELOCATION AND RECORDING number: . , initials/date: ' '- ;:f- ,, J - ,
0 R/LTR --+ KG/GR/LTR ---›
\ ' KOGR/LTR , . ,, ,,, , , KG/GR/LTR ---›,
,: , .
KG/GR/LTR ---> -• '''' ' ,, ,, , KG/GR/LTR -->3 ,
KG/GR/LTR --› KG/GR/LTR —›
KG/GR/LTR —÷ KG/GR/LTR ---›
KG/GR/LTR --+ KG/GR/LTR —+
KG/GR/LTR, --> KG/GR/LTR ---›
INITIALS/DATE
Certificate of Analysis
Productname: Nystatinum
Number of analysis/lnspection Code MON-177381B
Batchnumber: 18G18-1301
Reference code / No.: 2466
Analysed according to: PFLEUR 9.5
KEUR-164984B
/ 401 0236
Tests Requirement Result Unit Standard remark
Appearance Yellow or slightly brown powder Conform Hygroscopic
Fermentation According to Fermentation products Ph. Eur_ Conform Data producer
Identification B Conform Conform IR-spectrum
identification E Conform Conform HPLC
Absorbance >= 0,60 0,7 305nm, 0.001%m/V HAc / MeOH
Composition Conform Conform HPLC
Nystatin A1 >= 85,0 94,6 %m/m
Any other compound <= 4,0 1,8 3/0
Loss on drying <= 5,0 4,1 % 3 h 60"C in vacuo
Sulphated ash <= 3,5 =0,1 °A
Assay Nystatin >=5000 7853 ILJ/mg Microb_ assay of antib_, dried
Abnormal toxicity Conform Conform . According to supplier
Metallic residues CHMP/ICH/353369/2013 Conform Data producer
Residual solvents CPMP/ICH/82 260/06 Conform Data producer
TSE/BSE-statement: - No contamination with TSE/BSE-risk materials Conform Data producer
Release:dr. M.J. Vincenten - van MaanenPharmacist - Qualified Person
03-09-18
Expiration: 05-2021
Conclusion: APPROVED
This document has been produced electronically from our quality system and is valid without signature.
irk '
Science and soul
CERTIFICATE OF ANALYSIS No. 3597,
Product NYSTATIN
Analysis Record: 10.05.2018 Batch No. 401 0236 Quantity:162500 g
We S.C. ANTIBIOTICE S.A., as a manufacturer of Nystatin hereby certify that this bazch has been produced by us in full compliancewith the Certificate of GMP Compliance of Manufacturer No. 043/2016/RO issued by NANWD, valid starting with 29.11.2016.This batch has been manufactured, packaged and tested in accordance with EU GMP Guideline volume 4 part II (ICHQ7).
ANALYSES PERFORMED
Appearance
Solubitity
Identification
identification A.:A 230 / A 260
A 291 / A 309
A 319 / A 305
identification, Ultraviolet Absorption: A 250 / A 279 (sh)
Identification; B, C, D, EAbsorbance at 305 nmLoss on drying: - USP 40
- BP 2017, Eur. Ph. 9'1' EditionHeavy metalsSulphated ashAssay: - USP 40
- BP 2017 / Eur. Ph. 9' Edition
Abnormal toxicitySuspendibilityCr taltinitypH (3.0 % aqueous suspension)Composition:USP 40: - Nystatin Al
- Any other individu2J componentBP 2017/Eur. Ph. 9thEdition:
- Nystatin Al- Any other compound
CONDITIONS
Mfg. Date: 05.2018Exp. Date: 05.2021
Yettow or slightly brownish powder, hygroscopic.Yellow to light tan powder, having an odor suggestive of cereals. ishygroscopic, and is affected by •long exposure to light, heat, andair.Freely solubie in dimethylformamide and in dimethylsulfoxide;sparingly to slightly soluble in methanol, in n-propyl alcohol,and in n-butyl alcohol; practically insoluble in water and inalcohol; insolubte in chloroform and in etherAbsorption rnaxima at 230 nm, 291 nm, 305 nm and 319 nm, and ashoutder at 280 nm.
0.83 to 1.250.61 to 0.730.83 to 0.960.90 to 1.25in conformity with BP 2017 and Eur, Ph. 9'EditionNot less than 0.60
Not more than 5.0 %Not n-iore than 20 ppmNot rnore than 3.5 %Not less than 4400 USP Nystatin Units/mg, or, where intendedfor use in the extemporaneous preparation of oral suspensions,not less than 5000 USP Nystatin Units/mg 6205
RESULTS
yellow powder,hygroscopic; having anodor suggestiveof cereals
corresponds
corresponds
1.010.670.921.03corresponds0.81481.83.6< 200.6
Minimum 4400 1U/ mg (dried substance) and minimum5000 lUlrng (dded substance) if intended for orat administration 1 6437In conformity with BP 2017 and Eur. Ph. 9'Edition (2.6.9.) I corresponds
92.16Not less than 90.0 %It reveals birefringenceBetween 6.0 and 8.0
Minimurn 85.0 %I_Maximum 4.0 %
Minimum 85.0 %Maximum 4.0 %
corresponds7.9
90,431.52
91.111.52
Microbiological quality- TAMC, CFU/g
TYMC, CFU /gSpecified micro-organisms:
Not more than 10iNot more than 102
- Bile-tolerant gram-negative bacteria/ g Absent- Escherichia coli/g Absent- salmonella/ g Absent- Pseudomonas aeruginosal Absent- Staphylococcus aureus/g Absent
Residual sotvents: - Methanol Not n-iore than 0.3 %- Acetone Not more than 0.5 %
30<
absentabsentabsentabsentabsent0.010.20
Particle size,45 pm % As per ctient requirements
•
'This anaLysis s carried out periodically (1 batch for every 4 batches manufactured) 08,06,2,01895.29
STORAGE: Store in an airtight container, protected from tight at a temperature of 2°C to 8°C.pmpties with ttle--peciijcation of the BP 2017, Eur. Ph. 9t1] Edition and USP 40.
, C ,
Quality of,Quatity Control DepartmentMa rylagOY Ph-hico-Chernical Analyses
Giariiri Bu-Aileac• •
\ Wine! Miftode
.•1,, • „ ,r, „7.r, ),(-), . >-- \\D\ ,\-/-• ,
, I 1i
\ l . V a isp,2 L\e‘i 12;155i 7 0 74-la a rti I ar..0
+40 232 209 000+40 372 065 000~40 232 209 633
Head of Quality Control DepartmentMicrobiologiical and Pharmacodynarnical Analyses
Carmen Ruxandari
••• (.„ s•-•••••.,
office@antibioticelo• • ,
Product sample name Nystatinum; 500511Client-code 129Projt-c:-..ocie 0109641Batch numper 18G18-BOI
Ph. Eur. 01/7017:0517Version 1
estnb2,racters
ickritity B
Identity E.
Absorbance
Composition
Test methodMeafilid.MINIMMMIPMEWINIIMIM
Appearance
22.24
2.229
2.225
-9
Loss on dryin2 2.2„32.
sulfatt--,d
Assay
eecilication
Y e i i e w
te f"_,..,rence
Comlpared refi-Terice
powder
Ce Anaïysis
ResultÝe po\vder
CompliesLYP'.s
Conform (5x) Y '..;---. _-,
rinng,---rn,.._, ... , ,,,, , I ,.,.1 Yes
r ‘ --7,-,,..., . 1, Yes
NysLalin. Al: 85 .',r.",1 / 0 94.6 % Yesether ,oempound: 4 . o 1.8 % Yes
< 0/0 4.1 % v es
.5 % < 0.1 % Yes
7851, nijrng Yes3000 IU/mg
QA-staternent:This sradv met the criteria ft)r a valid test and. was performed in compliance ‘vith the Good control Laboratory Practiceas defined in the Guide to Good ManufacturinE Practice for Medicinal Products in the European Community.The r orrc=d ccssdts adeccuatelyr-fle-7,t thc raw data of t.h. study.
Conciusion-_The results do comply with the spezifications
This certificate is approved. by Manag r OA on 29 Auzust 201
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