C Lack of or inadequate Inprocess acceptance procedures for the control product have not been adequately established. Storage transportation of finished goods contamination Failure store food under conditions that would protect against physical chemical microbial . Manufacturing You did not conduct operations accordance with adequate sanitation principles [...]
B Floors walls and ceilings The plant is not constructed such manner as to allow be adequately cleaned kept good repair. Written control operations You did not establish follow procedures for quality [...]
Records of process establishment Complete covering all aspects the scheduled for incubation tests associated with establishing were not prepared permanently retained by person organization making determinati CFR. c Specifications metverify finished batch You did not that your of dietary supplement meets product for identity purity strength composition limits contamination may adulterate lead to adulteration the . f Labeling of blood products unsuitable for transfusion Failure to prominently and components determined with NOT the reason unit is considered . Thermometers Failure to equip each refrigerator with located in warmest region thereof. Although many colorants and mix ratios of activators resins are critical silicone molding processes traditional device manufacturing do not require calculation yield [...]
A Components withheld from use pending release Each lot of drug product containers closures is not until the has been sampled tested examined and released by quality control unit. a Storage Failure store raw materials in manner that protects against contamination minimizes deterioration. Reserve Samples This whitepaper examines ProMed approach to implementing QMS elements that satisfy these requirements. b Conveyor transportation Failure to take effective measures protect food transported by from contamination [...]
C Study director unforeseen circumstances The failed assure that might affect quality and integrity of nonclinical laboratory were noted when they occurred corrective action was taken documented. Prevention of the spread communicable diseases Servicing area not provided with all necessary sanitary facilities operated maintained to [...]
A Specific nonconforming product procedures addressing the identification documentation evaluation segregation disposition investigation of were not defined documented complete. b Coderequired elements Each container is not marked with an identifying specifying the establishment where product was packed contained therein year date packing period. c Availability of procedures for core CTGP requirements were not available to personnel in the area where operations performed nearby when such is impractical. Design controls [...]
G Representative samplesbottled water collected for bacteriological chemical physical radiological analysis were not primary containers unit packages from batch segment of continuous production run each type drinking . requirements that must be met by suppliers contractors consultants have not been adequately established. d Written Procedures to Remove Pyrogens There are no standards or specifications methods of testing cleaning sterilization processing pyrogenic properties. b Maintenance of equip [...]
B Examination for accuracy Labeling was not sufficiently examined by designated individual including the correct expiration date control numbers storage instructions handling certain additional processing before release. g Record of all test data Laboratory records did not contain complete obtained the course each . b Processing and information The production records do not contain sufficient additional such as code date container size to permit public health hazard evaluation of processes applied each lot batch portion CFR. a Reporting findings and actions to investigator institution The IRB has no did not follow its written procedure for [...]
B Any labeling or packaging materials meeting appropriate written specifications may approved and released for use. a iv C Calibration testingrecord review timeliness You did not all of your periodic endproduct inprocess records within reasonable after the were made. e Quality periodic testing Your control personnel did not review and approve the basis documentation for why component inprocess examination monitoring other method will ensure that exempted product specification without verification through CFR. Assuring correct labels are used not received handled stored manner that prevents mixups assures the for medicated feed [...]
Quarantine of Rejected Components et. Equipment Design Size and Location used in the manufacture processing packing or holding of drug products is not appropriate adequate suitably located to facilitate operations for its intended cleaning maintenance. d Acceptance Rejection Levels The statistical quality control criteria fail to include appropriate [...]
C Physical plantreceiving holding identifying You did not have use separate or defined areas of adequate size other control systems to prevent contamination mixups components and dietary supplements during withholding from CFR. b qualification You did not make and keep documentation of your supplier [...]
A Hold identifyin process material You did not and inprocess under conditions that protect against mixup contamination or deterioration. a Changes to correct prevent quality problems in methods and procedures needed identified are not implemented recorded effective. b Adequate drainage The building grounds are not adequately drained so that they free from standing water [...]
