FDA Dietary Supplement cgmp

Transcription

1 FDA Dietary Supplement cgmp FEBRUARY 2009 OVERVIEW Summary The Fd and Drug Administratin (FDA) has issued a final rule regarding current gd manufacturing practices (cgmp) fr dietary supplements that establishes the minimum requirements fr manufacturing, packaging, labeling r hlding f dietary supplements t ensure that prducts meet apprpriate quality standards. Refer t Part 111 Current Gd Manufacturing Practice in Manufacturing, Packaging, Labeling, r Hlding Operatins fr Dietary Supplements: Cmpliance dates were staggered dependent n the size f the cmpany: June 25, 2008 cmpanies > 500 June 25, 2009 cmpanies f June 25, 2010 cmpanies < 20 Definitin f Dietary Supplement A dietary supplement: Is a prduct (ther than tbacc) that is intended t supplement the diet that bears r cntains ne r mre f the fllwing dietary ingredients: a vitamin, a mineral, an herb r ther btanical, an amin acid, a dietary substance fr use by man t supplement the diet by increasing the ttal daily intake, r a cncentrate, metablite, cnstituent, extract, r cmbinatins f these ingredients. Mississauga, Ontari inf@qualityandcmpliance.cm Is intended fr ingestin in pill, capsule, tablet, r liquid frm. Is nt represented fr use as a cnventinal fd r as the sle item f a meal r diet. Is labeled as a "dietary supplement." Includes prducts such as an apprved new drug, certified antibitic, r licensed bilgic that was marketed as a dietary supplement r fd befre apprval, certificatin, r license (unless the Secretary f Health and Human Services waives this prvisin). NHP Cmpliance is a divisin f Quality & Cmpliance Services Inc. 1

2 WHO DOES THIS APPLY TO Manufacturers, Packagers, Labelers, and strage facilities. KEY POINTS The GMPs are divided int varius sectins and in every case written prcedures and recrds are required. Persnnel Micrbial cntaminatin is avided thrugh apprpriate health and hygienic practices. The persn respnsible fr quality cntrl is identified. Persnnel perfrming quality cntrl functins are qualified and have distinct and separate respnsibilities when perfrming these functins. Persnnel have the educatin training r experience necessary t perfrm the assigned functins. Facility Grunds are maintained s as t prevent cntaminatin. The physical plant is maintained in a clean and sanitary cnditin. Water used must meet all Federal, State and lcal requirements. There must be written prcedures and recrds fr cleaning and pest cntrl f the facility. Mississauga, Ontari The plant must be designed s as t prevent cntaminatin and mix-ups and t allw fr apprpriate cleaning and maintenance f equipment. There must be adequate ventilatin r envirnmental cntrl equipment t prevent cntaminatin. There must be adequate lighting. inf@qualityandcmpliance.cm NHP Cmpliance is a divisin f Quality & Cmpliance Services Inc. 2

3 Equipment and Utensils Equipment used in the manufacturing and testing must be rutinely calibrated. There must be prcedures fr maintaining, cleaning and sanitizing equipment and utensils in direct cntact with the dietary supplement. The equipment must be designed t prevent cntaminatin f the prduct. Cld strage equipment must be fitted with a temperature mnitring device and must have an autmated device fr regulating temperature, r be cnnected t autmated alarm system. Instruments r cntrls used must be accurate and precise, adequately maintained, and sufficient in number. All equipment must be maintained, cleaned and sanitized. Autmated mechanical r electrnic equipment must be selected t ensure that prduct specificatins are cnsistently met, that the equipment is capable f perating within the required perating limits. Prductin and Prcess Cntrls There must be a quality cntrl peratin. Specificatins must be established fr every stage in the prcess where cntrl is required: All cmpnents used and each prduct manufactured must have specificatins including identity, purity, strength and limits n cntaminatin. Mississauga, Ontari In-prcess specificatins must be established fr any part f the prcess where cntrl is necessary. Packaging and labeling must have apprved specificatins. Reprcessing may nly ccur if quality cntrl has cnducted an investigatin and apprved the reprcessing based n scientifically valid reasning. inf@qualityandcmpliance.cm NHP Cmpliance is a divisin f Quality & Cmpliance Services Inc. 3

4 The fllwing recrds must be maintained: Specificatins Supplier qualificatin Justificatin fr in-prcess testing Justificatin fr reduced finished prduct testing, if applicable Quality Cntrl Quality cntrl is respnsible t: Apprve all prcesses, specificatins, prcedures, cntrls, tests and deviatins. Ensure all samples are taken and that reserve samples are held. Determine that all specificatins are met. Review and apprve labratry prcesses. Cnduct an investigatin if specificatins are nt met, there is a deviatin r an unanticipated ccurrence during manufacture. Review and apprve all master manufacturing recrds, in-prcess tests and reprcessing. Review and release f each batch f finished prduct. Review and apprve the cnditin f any prduct returned t the facility, prir t re-distributin. Review and apprve decisins regarding the investigatin f any cmplaint received. Mississauga, Ontari inf@qualityandcmpliance.cm NHP Cmpliance is a divisin f Quality & Cmpliance Services Inc. 4

5 Raw Materials, Packaging and Labeling Each receipt must be inspected, sampled and results f testing cmpared against specificatins. Each lt must be uniquely identified. Lts are released by quality cntrl. Rejected items must be clearly labeled and held under quarantine. Master Manufacturing Recrds A master manufacturing recrd must be prepared fr each unique frmulatin and batch size, including instructins fr each stage f prductin, sampling and specificatins fr each cntrl pint, expected yields and prvisins fr verificatins f the weights and additins f each cmpnent. Batch Prductin Recrd There must be a prductin recrd fr each batch prduced, referencing cleaning and sanitizatin actins, the lt numbers f each cmpnent used, yields, test results and dates, times and initials f the activities. Labratry Operatins Prcedures must be apprpriate and scientifically valid. They must be signed by quality cntrl. Recrds f all tests cnducted must be maintained. Manufacturing Operatins Mississauga, Ontari Manufacturing peratins must be carried ut under cnditins that guard against the cntaminatin f the prduct. inf@qualityandcmpliance.cm NHP Cmpliance is a divisin f Quality & Cmpliance Services Inc. 5

6 Packaging and Labeling Operatins Packaging peratins must be carried ut under cnditins that guard against cntaminatin f the prduct. An actual label r representatin must be retained and must be cmpared t the label in the master prductin recrd. Packaging and labels must be recnciled unless the label n the finished prduct is examined electrmechanically. Hlding and Distributing Prducts and cmpnents must be held and distributed under apprpriate strage cnditins. Distributin recrds must be maintained. Returns Returns must be quarantined n receipt and nly released after a material review is cnducted by quality cntrl. Prduct Cmplaints All cmplaints must be reviewed and any pssible failure must be investigated. This review and any subsequent investigatin must be reviewed by quality cntrl. Recrds and Recrdkeeping Recrds must be maintained fr ne year past the shelf life f the prduct r tw years past the date f distributin f the last batch f prduct assciated with thse recrds. Mississauga, Ontari Required recrds must be available fr review by the FDA n request. inf@qualityandcmpliance.cm NHP Cmpliance is a divisin f Quality & Cmpliance Services Inc. 6

7 FAQ 1. What is a dietary supplement? A dietary supplement: Is a prduct (ther than tbacc) that is intended t supplement the diet that bears r cntains ne r mre f the fllwing dietary ingredients: a vitamin, a mineral, an herb r ther btanical, an amin acid, a dietary substance fr use by man t supplement the diet by increasing the ttal daily intake, r a cncentrate, metablite, cnstituent, extract, r cmbinatins f these ingredients. Is intended fr ingestin in pill, capsule, tablet, r liquid frm. Is nt represented fr use as a cnventinal fd r as the sle item f a meal r diet. Is labeled as a "dietary supplement." Includes prducts such as an apprved new drug, certified antibitic, r licensed bilgic that was marketed as a dietary supplement r fd befre apprval, certificatin, r license (unless the Secretary f Health and Human Services waives this prvisin). 2. What is a new dietary ingredient? A new dietary ingredient is a dietary ingredient that was nt sld in the United States in a dietary supplement befre Octber 15, What claims can manufacturers make fr dietary supplements and drugs? Mississauga, Ontari inf@qualityandcmpliance.cm The label f a dietary supplement r fd prduct may cntain ne f three types f claims: a health claim, nutrient cntent claim, r structure/functin claim. Health claims describe a relatinship between a fd, fd cmpnent, r dietary supplement ingredient, and reducing risk f a disease r healthrelated cnditin. Nutrient cntent claims describe the relative amunt f a nutrient r dietary substance in a prduct. A structure/functin claim is a statement describing hw a prduct may affect the rgans r systems f the bdy and it can nt mentin any specific disease. Structure/functin claims d nt require FDA apprval but the manufacturer must prvide FDA with the text f the claim within 30 days f putting the prduct n the market. NHP Cmpliance is a divisin f Quality & Cmpliance Services Inc. 7

8 Prduct labels cntaining such claims must als include a disclaimer that reads, "This statement has nt been evaluated by the FDA. This prduct is nt intended t diagnse, treat, cure, r prevent any disease." FEBRUARY 2009 Drug manufacturers may claim that their prduct will diagnse, cure, mitigate, treat, r prevent a disease. Such claims may nt legally be made fr dietary supplements. 4. Hw des FDA regulate dietary supplements? In additin t regulating label claims, FDA regulates dietary supplements in ther ways. Supplement ingredients sld in the United States befre Octber 15, 1994, are nt required t be reviewed by FDA fr their safety befre they are marketed because they are presumed t be safe based n their histry f use by humans. Fr a new dietary ingredient (ne nt sld as a dietary supplement befre 1994) the manufacturer must ntify FDA f its intent t market a dietary supplement cntaining the new dietary ingredient and prvide infrmatin n hw it determined that reasnable evidence exists fr safe human use f the prduct. FDA can either refuse t allw new ingredients int r remve existing ingredients frm the marketplace fr safety reasns. Manufacturers d nt have t prvide FDA with evidence that dietary supplements are effective r safe; hwever, they are nt permitted t market unsafe r ineffective prducts. Once a dietary supplement is marketed, FDA has t prve that the prduct is nt safe in rder t restrict its use r remve it frm the market. The label f a dietary supplement prduct is required t be truthful and nt misleading. If the label des nt meet this requirement, FDA may remve the prduct frm the marketplace r take ther apprpriate actins. 5. Is there a mngraph system fr dietary supplements? Mississauga, Ontari There is n system in the U.S.A. fr dietary supplement mngraphs and n requirement t standardize them. The presence f the wrd "standardized" n a supplement label des nt necessarily indicate prduct quality. inf@qualityandcmpliance.cm NHP Cmpliance is a divisin f Quality & Cmpliance Services Inc. 8

9 6. What methds are used t evaluate the health benefits and safety f a dietary supplement? Scientists use several appraches t evaluate dietary supplements fr their ptential health benefits and safety risks, including their histry f use and labratry studies using cell r animal studies. Studies invlving peple (individual case reprts, bservatinal studies, and clinical trials) can prvide infrmatin that is relevant t hw dietary supplements are used. Researchers may cnduct a systematic review t summarize and evaluate a grup f clinical trials that meet certain criteria. A meta-analysis is a review that includes a statistical analysis f data cmbined frm many studies. 7. What are sme additinal surces f infrmatin n dietary supplements? PubMed - FDA - Fr general infrmatin n btanicals and their use as dietary supplements, see Backgrund Infrmatin Abut Btanical Dietary Supplements - Cntact NHP Cmpliance with yur questins abut Natural Health Prducts. Phne Graham Mills tll-free at , extensin 210, r him at gmills@qualityandcmpliance.cm. Mississauga, Ontari NHP Cmpliance QuickNte -- Date f last update: February inf@qualityandcmpliance.cm NHP Cmpliance is a divisin f Quality & Cmpliance Services Inc. 9