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All new products make out,we have strict quality control and test.we do will do the test in those sample.

1. HGH samples should be tested according to following items

 

Items of Test Standard
Characters   White lyophilized powder
Identification    
A. IEF CORRESPONDS TO THE REFERENCE
B. HPLC/RP CORRESPONDS TO THE REFERENCE
C. PEPTIDE MAPPING CORRESPONDS TO THE REFERENCE
D. HPLC/SEC CORRESPONDS TO THE REFERENCE
RELATED PROTEINS (HPLC/RP)   ≤ 13.0%
DIMER&RELATED SUBSTANCES
OF HIGHER MOLECULAR MASS
(HPLC/SEC)
  ≤ 6.0%
ISOFORM DISTRIBUTION   CORRESPONDS TO THE REFERENCE
WATER   ≤ 3.0%
BACTERIAL ENDOTOXINS   < 5.0 IU/mg hGH
HOST-CELL-DRIVED PROTEINS   ≤ 30 ng/mg hGH
HOST-CELL & VECTOR-DERIVED DNA   ≤ 10 ng/dose hGH
TEST FOR STERILITY   conformed
ASSAY (HPLC/SEC)   89.0% - 105.0 % the amount of Somatropin stated on the label
Purity (HPLC)   ≥ 95%
 

2. Endotoxin Control

 

Endotoxin contamination of an injectable product can occur as a result of poor CGMP controls.Certain patient populations (e.g., neonates), those receiving other injections concomitantly, or those administered a parenteral in atypically large volumes or doses can be at greater risk for pyrogenic reaction than anticipated by the established limits based on body weight of a normal
healthy adult (Ref. 6, 7). Such clinical concerns reinforce the importance of exercising appropriate CGMP controls to prevent generation of endotoxins. Drug product components,containers, closures, storage time limitations, and manufacturing equipment are among the areas to address in establishing endotoxin control.


Adequate cleaning, drying, and storage of equipment will control bioburden and prevent contribution of endotoxin load. Equipment should be designed to be easily assembled and disassembled, cleaned, sanitized, and/or sterilized. If adequate procedures are not employed,endotoxins can be contributed by both upstream and downstream processing equipment.


Sterilizing-grade filters and moist heat sterilization have not been shown to be effective in removing endotoxin. Endotoxin on equipment surfaces can be inactivated by high-temperature dry heat, or removed from equipment surfaces by cleaning procedures. Some clean-in-place procedures employ initial rinses with appropriate high purity water and/or a cleaning agent (e.g.,
acid, base, surfactant), followed by final rinses with heated WFI. Equipment should be dried following cleaning, unless the equipment proceeds immediately to the sterilization step.

 

 

3. Microbiological Media and Identification

 

Characterization of recovered microorganisms provides vital information for the environmental monitoring program. Environmental isolates often correlate with the contaminants found in a media fill or product sterility testing failure, and the overall environmental picture provides valuable information for an investigation. Monitoring critical and immediately surrounding clean areas as well as personnel should include routine identification of microorganisms to the
species (or, where appropriate, genus) level. In some cases, environmental trending data have revealed migration of microorganisms into the aseptic processing room from either uncontrolled or lesser controlled areas. Establishing an adequate program for differentiating microorganisms
in the lesser-controlled environments, such as Class 100,000 (ISO 8), can often be instrumentalin detecting such trends. At minimum, the program should require species (or, where appropriate, genus) identification of microorganisms in these ancillary environments at frequent intervals to establish a valid, current database of contaminants present in the facility during
processing (and to demonstrate that cleaning and sanitization procedures continue to be effective).


Genotypic methods have been shown to be more accurate and precise than traditional biochemical and phenotypic techniques. These methods are especially valuable for investigations into failures (e.g., sterility test; media fill contamination). However, appropriate biochemical and phenotypic methods can be used for the routine identification of isolates. The goal of microbiological monitoring is to reproducibly detect microorganisms for purposes of
monitoring the state of environmental control. Consistent methods will yield a database that allows for sound data comparisons and interpretations. The microbiological culture media used in environmental monitoring should be validated as capable of detecting fungi (i.e., yeasts and molds) as well as bacteria and incubated at appropriate conditions of time and temperature.


Total aerobic bacterial count can be obtained by incubating at 30 to 35 o C for 48 to 72 hours.Total combined yeast and mold count can generally be obtained by incubating at 20 to 25 o C for 5 to 7 days.

Incoming lots of environmental monitoring media should be tested for their ability to reliably recover microorganisms. Growth promotion testing should be performed on all lots of prepared media. Where appropriate, inactivating agents should be used to prevent inhibition of growth by cleanroom disinfectants or product residuals (e.g., antibiotics).

 

 

3. TIME LIMITATIONS


When appropriate, time limits must be established for each phase of aseptic processing. Time limits should include, for example, the period between the start of bulk product compounding and its sterilization, filtration processes, product exposure while on the processing line, and storage of sterilized equipment, containers and closures. The time limits established for the various production phases should be supported by data. Bioburden and
endotoxin load should be assessed when establishing time limits for stages such as the formulation processing stage.


The total time for product filtration should be limited to an established maximum to prevent microorganisms from penetrating the filter. Such a time limit should also prevent a significant increase in upstream bioburden and endotoxin load. Because they can provide a substrate for microbial attachment, maximum use times for those filters used upstream for solution clarification or particle removal should also be established and justified.