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GMP Certification

GMP (Good Manufacturing Practices) guidelines are established by the Food and Drug Administration to assist food manufacturers in the production of unadulterated products. Under a Silliker Food Safety / GMP audit, companies must comply with recognized standards in their overall programs and execution related to their grounds, building and equipments. Good Manufacturing Practices are guidelines that provide a system of processes, procedures, and documentation to assure the product produced has the identity, strength, composition, quality, and purity that it is represented to possess. Good Manufacturing Practices (GMP, also referred to as 'cGMP' or 'current Good Manufacturing Practice') is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification. GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration. These regulations, which have the force of law. If a manufacturer decides not to upgrade an entire facility to meet the new GMP requirements, it may transfer certain manufacturing technologies to manufacturers that are already certified with new GMP.Good M?nuf??tur?ng Pr??t??? (GMP) ?? a t?rm th?t ?? r???gn?z?d w?rldw?d? for th? ??ntr?l ?nd m?n?g?m?nt ?f m?nuf??tur?ng, t??t?ng ?nd ?v?r?ll quality ??ntr?l ?f food ?nd ?h?rm???ut???l products. GMP takes quality ???ur?n?? ???r???h, wh??h ensures th?t ?r?du?t? ?r? consistently ?r?du??d ?nd controlled to the quality ?t?nd?rd? appropriate to th??r intended u?? ?nd as r??u?r?d b? th? marketing authorization. GMP ?? aimed primarily ?t d?m?n??h?ng th? r??k? ?nh?r?nt ?n ?n? Ph?rm???ut???l ?r Food ?r?du?t??n. GMP addresses ???u?? including d??um?nt?t??n, r???rd keeping, personnel qualifications, ??n?t?t??n, ?l??nl?n???, ??u??m?nt v?r?f???t??n, process validation, ?nd ??m?l??nt h?ndl?ng. Most GMP r??u?r?m?nt? ?r? v?r? g?n?r?l ?nd ???n?nd?d, ?ll?w?ng ???h manufacturer to d???d? individually h?w to best implement th? necessary ??ntr?l?. This provides much fl?x?b?l?t?, but also r??u?r?? that th? manufacturer interprets th? r??u?r?m?nt? ?n a m?nn?r wh??h m?k?? ??n?? f?r each ?nd?v?du?l bu??n??? An ?m??rt?nt ??rt ?f GMP, “d??um?nt?t??n” ?f ?v?r? ?????t ?f the ?r?????, ??t?v?t???, ?nd ???r?t??n? involved w?th manufacture. If the d??um?nt?t??n ?h?w?ng how th? ?r?du?t w?? m?d? ?nd tested ?? n?t correct ?nd in ?rd?r, then th? ?r?du?t d??? not m??t th? r??u?r?d ?????f???t??n ?nd ?? ??n??d?r?d ??nt?m?n?t?d (?dult?r?t?d ?n the US). Add?t??n?ll?, GMP requires th?t ?ll m?nuf??tur?ng and testing equipment h?? b??n qualified as suitable f?r u??, ?nd that ?ll operational m?th?d?l?g??? ?nd procedures, ?u?h as m?nuf??tur?ng, cleaning, ?nd ?n?l?t???l testing, utilized ?n th? drug or food manufacturing ?r????? have b??n v?l?d?t?d to d?m?n?tr?t? th?t they ??n perform th??r ?ur??rt?d fun?t??n?. The ?u?l?t? ???r???h ?f GMP ?n?ur?? m?nuf??tur?ng, enabling companies t? m?n?m?z? ?r eliminate instances ?f contamination, m?xu??, ?nd ?rr?r?. This ?n turn, ?r?t??t? th? ??n?um?r from purchasing a ?r?du?t, which ?? n?t effective or ?v?n dangerous. F??lur? of f?rm? t? comply w?th GMP r?gul?t??n? can result in very serious consequences ?n?lud?ng r???ll, seizure, fines, and j??l t?m?. It ?? believed that GMP is a g??d bu??n??? t??l, wh??h w?ll h?l? to r?f?n? both ??m?l??n?? and ??rf?rm?n?? ?f th? C?m??n?. GMP r??u?r?m?nt? ?r? l?rg?l? ??mm?n sense ?r??t????, which w?ll help ??m??n??? b?tt?r itself as ?t m?v?? toward a ?u?l?t? ???r???h u??ng continuous ?m?r?v?m?nt. GMP ?? ?l?? ??m?t?m?? r?f?rr?d t? ?? "?GMP". Th? "?urr?nt," methodologies of m?nuf??tur?, t??t?ng, d???gn ?nd control. Th? M?nuf??tur?r? mu?t ?m?l?? technologies and ???t?m?, wh??h ?r? u?-t?-d?t?. S??t?m? ?nd equipment u??d t? ?r?v?nt ??nt?m?n?t??n, m?xu?? and ?rr?r? ?r? adequate b? today's standards. Thu?, Good M?nuf??tur?ng Pr??t???? –GMP, when certified of a ?rg?n?z?t??n, is ?n ?uth?r???t??n and ??rt?f???t??n of Companies product & ?r????? that ?u?l?t? ?t?nd?rd? ?r? adequate, u? t? d?t? and controlled for th? ?nt?nd?d u?? b? the consumer.Regulatory Gu?d?l?n?? ?nd St?nd?rd?Th? G??d Manufacturing Pr??t??? (GMP) ??rt?f???t? issued by HSA is a certificate relating t? th? manufacture ?f a th?r???ut?? ?r?du?t, m?d???n?l product, an active ?h?rm???ut???l ?ngr?d??nt ?r a ???m?t?? ?r?du?t attesting to its conformity with th? r?l?v?nt GMP St?nd?rd ?? appropriate. A GMP ??rt?f???t? is gr?nt?d when the m?nuf??tur?ng f???l?t? has b??n audited and f?und t? d?m?n?tr?t? ??t??f??t?r? ??m?l??n?? with th? required GMP ?t?nd?rd. Th? name ?nd ?ddr??? ?f th? m?nuf??tur?ng ??t? ?nd th? scope ?f th? ??rt?f???t??n w?ll be d?f?n?d ?n th? GMP ??rt?f???t?. The ????? of certification w?uld n?rm?ll? b? d?t?rm?n?d b? th? ????? ?f th? actual ?ud?t th?t w?? performed ?t th? manufacturing f???l?t? ?nd th? types ?f dosage forms/range of products b??ng manufactured. A GMP certificate w?uld n?rm?ll? b? v?l?d f?r 3 years fr?m th? d?t? ?f ??????m?nt. Th? certificate w?uld b? ???u?d ?n th? n?m? ?f th? l???l firm/company r?g??t?r?d w?th th? Accounting ?nd C?r??r?t? Regulatory Authority, Singapore. Th? ??r??n m?k?ng the ???l???t??n should b? ?uth?r?z?d b? the ??m??n? t? d? ?? as th? person r????n??bl? (?.g. M?n?g?ng D?r??t?r, QA/QC M?n?g?r, Pr?du?t??n M?n?g?r). Assurance ?f the ??f?t? ?nd ?u?l?t? of f??d ?? a ?m??rt?nt ??n??d?r?t??n f?r consumers today. A GMP ?? ?n ?m??rt?nt ?nh?n??m?nt to ??ur f??d safety m?n?g?m?nt ???t?m, which ?n?r????? your customers’ ??nf?d?n?? in ??ur commitment t? trading ?nd ?r?du??ng ??f?, h?gh qual?t? f??d. Steps f?r GMP CertificationD?f?ne Standards By organizationTr??n?ng By organizationE?t?bl??h S??t?m By organizationD??um?nt?t??n & R???rd By organizationAud?t By UQSR (Certification Body)Aud?t By UQSR (Certification Body)Certification By UQSR (GMP Certification Body)G??d m?nuf??tur?ng practice gu?d?l?n?? provide gu?d?n?? for m?nuf??tur?ng, testing, ?nd quality ???ur?n?? ?n ?rd?r t? ?n?ur? that a m?nuf??tur?d ?r?du?t ?? ??f? for hum?n consumption or u??. Many countries h?v? legislated th?t m?nuf??tur?r? f?ll?w GMP procedures ?nd create th??r own GMP gu?d?l?n?? th?t correspond with their l?g??l?t??n.  GMP gu?d?l?n? f?ll?w? an f?w b???? ?r?n???l??:Manufacturing f???l?t??? must m??nt??n a ?l??n ?nd hygienic m?nuf??tur?ng area. Manufacturing f???l?t??? must maintain controlled ?nv?r?nm?nt?l conditions ?n order t? prevent ?r???-??nt?m?n?t??n fr?m ?dult?r?nt? and allergens th?t m?? r?nd?r th? ?r?du?t un??f? f?r human ??n?um?t??n or u??.  M?nuf??tur?ng ?r??????? mu?t be clearly d?f?n?d ?nd ??ntr?ll?d. All critical ?r??????? ?r? v?l?d?t?d t? ?n?ur? consistency ?nd ??m?l??n?? w?th ?????f???t??n?. M?nuf??tur?ng ?r??????? mu?t be ??ntr?ll?d, and ?n? changes t? the ?r????? mu?t b? evaluated. Ch?ng?? th?t ?ff??t th? ?u?l?t? ?f the drug ?r? v?l?d?t?d as n??????r?. Instructions and ?r???dur?? mu?t b? wr?tt?n ?n clear and unambiguous language using g??d d??um?nt?t??n practices.  Records of m?nuf??tur? (including distribution) that ?n?bl? the ??m?l?t? h??t?r? of a b?t?h t? b? tr???d mu?t b? r?t??n?d ?n a ??m?r?h?n??bl? and ???????bl? f?rm. G??d m?nuf??tur?ng practices are r???mm?nd?d w?th th? goal of safeguarding th? h??lth ?f ??n?um?r? ?nd patients ?? w?ll as ?r?du??ng quality ?r?du?t?. In th? Un?t?d St?t??, a food ?r drug may b? deemed "adulterated" ?f ?t h?? ?????d ?ll of the ?????f???t??n? t??t? but ?? f?und t? be m?nuf??tur?d ?n a facility ?r ??nd?t??n wh??h v??l?t?? ?r d??? not ??m?l? w?th current g??d manufacturing gu?d?l?n?. GMP gu?d?l?n?? ?r? not ?r???r??t?v? instructions on h?w t? m?nuf??tur? ?r?du?t?. They are a ??r??? ?f g?n?r?l ?r?n???l?? th?t must b? ?b??rv?d during m?nuf??tur?ng. When a ??m??n? is setting up ?t? ?u?l?t? ?r?gr?m and m?nuf??tur?ng process, there m?? b? m?n? w??? it ??n fulf?ll GMP requirements. It is th? company's r????n??b?l?t? to d?t?rm?n? the most ?ff??t?v? ?nd ?ff????nt quality process th?t b?th m??t? bu??n??? ?nd r?gul?t?r? needs. A G??d Manufacturing Pr??t???? (GMP) certification ??h?m? ?r?v?d?? ?nd???nd?nt v?r?f???t??n ?nd certification th?t th? b???? manufacturing ?r??t???? and ?r?r??u???t?? necessary for th? ?m?l?m?nt?t??n of an effective H?z?rd An?l???? Cr?t???l C?ntr?l Point (HACCP) food safety ?r?gr?m ?r? b??ng f?ll?w?d. UQSR ?? a w?rld leader in th?rd ??rt? certification ?nd v?r?f???t??n. C?rt?f??ng ??ur f??d ??f?t? m?n?g?m?nt ???t?m ?g??n?t Good Manufacturing Pr??t???? requirements w?th UQSR ?n excellent w?? t? ?r???r? f?r inspections b? r?gul?t?r? ?uth?r?t??? and ?th?r stakeholders. Th? process w?ll help ??u to ensure r?gul?t?r? ??m?l??n?? wh?l? d?m?n?tr?t?ng ??ur kn?wl?dg? ?f the ?m??rt?n?? of ?r?du??ng and trading safe, quality food. C?nt??t UQSR to l??rn m?r? ?b?ut th? GMP ??rt?f???t??n process. C?m?l??n?? with GMP r?quir?m?nt? ?nt??l? minimum common ??n?? sanitary ?nd ?r??????ng requirements ???l???bl? to ?ll food ?r??????ng ??t?bl??hm?nt?. M?n? food industry companies have ?m?l?m?nt?d th? GMP certification scheme f?r food processing ?? the f?und?t??n upon wh??h they h?v? d?v?l???d and implemented ?th?r quality ?nd f??d ??f?t? management ???t?m?, ?n?lud?ng HACCP, ISO 22000, SQF ?nd ISO 9001.