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sunever biology company limited
The company has nearly 20 years’ experience of dietary supplement research, development and production. The dosage contains soft capsule, tablet, hard capsule, powder, granule and pill. The company
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sunever biology company limited Quality Info

sunever biology company limited
Quality Control

Take product quality as management target, control entire relative elements concerning product quality monitor complete manufacturing course, ensure to offer customers the product met standard regulations and offer satisfying service.
1.Management for material section
1)The process flow for suppliers sift & assessment
2)Material sampling, check/accept and release for production
3)The treatment flow for NG material
4)Check for label draft & confirm the standard label sheet
 5)Standardize the name of material and confirm the code of material
 6)Inspect before product export factory
 7)Management of remained samples for each batch
8)On line quality inspection for warehouse
2.Management of production locale
 1)Monitor for production process flow
 2)Control for environment of the clean area
 3)The key control station for GMP workshop
 4)Management for measuring apparatus
 5)Quality analysis for the production process
 6)Finished product release
3.Laws support
 1)After sales service for product
 2)Hold national documents of rules & laws, carry out & execute
 3)Standardization

4)Licenses apply, check & certificate update
 5)Promote the regulations of trade
 6)Management for record files

Quality Control Flow Chart

1. Management for material section
1)The process flow for suppliers sift & assessment

2)Material sampling, check/accept and release for production
①Sampling: Compile sampling plan & SOP, sampling should be representative.
②Check and accept: Judgment for raw material & supplement agent, appearance properties via QC check; daily check & accept packing material via QC check;
General physical & chemical test: The value of acid, peroxide, SAPONIFICATION, pH, thin layer chromatogram distinguish, relative density, refraction rate, dry weight lost, ash content and burned DRAFF;
Microbe Limited Test: Bacteria colony-forming units, mildew, MICROZYME, COLIBACILLUS, SALMONELLA, SHIGELLA, Staphylococcus AUREUS and hemolytic streptococcus;
Heavy Metal: lead, arsenic & mercury etc;
Active ingredient content determine: Method of High Efficiency Liquid Phase Chromatogram, Method of Gaseous Phase Chromatogram, Method of Atom Fluorescence SPECTROPHOTOMETRY, Atom Absorbing SPECTROPHOTOMETRY, Ultraviolet-Sight light SPECTROPHOTOMETRY and Titration.
③Release for production: QA issued certificate for qualified material and execute Management Flow for NG material.
3)The treatment flow for NG material

4)Check for label draft & confirm the standard label sheet
①Check for label design draft;
②Check for first printed edit of label, setup standard sample label;
③Appoint OEM product, customer offer standard sample label of the product;
④Check and accept content: Letters, design, colors, cutting quality, direction of label roll and sticky quality of the adhesive labeler etc.
5)Standardize the name of material and confirm the code of material
①Raw material and assistant agent: Name + Specification + Suppliers (Manufacturers), clearly indicate period of validity
②Inner Packing Material: Sorts + Material Quality + Specifications + Colors + Suppliers
③Outside Packing Material: Labeler, Manual Instruction, Small Box & Middle Box
Cartons & Al. Foil: Name + Brand + Specification + Edit Number + Suppliers
Paper Board Inserting, Clapboard, Sealing Film & Plastic Sheet Forming:
Name + Specification + Suppliers
6)Inspect before product export factory
①Name of customer
②Product Name & Specification
③Quantity
④Inner & Outside Package
⑤Labeler Instruction
7)Management of remained samples for each batch
①Management for Sampling Remain Room
The sampling remain room is individual with lock & special management person. The samples storage condition should meet the requirements of regulation with label instruction, record of temperature & humidity. The sample remained should be registered on time, before out-warehouse, it must be approval & keep record in detail.
②Items of sample observe
Key samples as per the regulations of stability test management, process inspection, normal samples every three mouths to check the appearance and yearly according to the standard check entire properties.
③Storage Term
Material: As per material storage regulations, at least more than one year
Finished Product: After period of validity + one year
8)On line quality inspection for warehouse
①On line quality inspection for material & finished product in warehouse, find trouble immediately solve.
②Management for the product near validity
③Previous imported material exported first and previous produced finished products sell first
④Check before stored products export & write opinion to solve
2. Management of production locale
 1)Monitor for production process flow
Gelatin Melting Process
The contents in middle monitor during gelatin melting process
1. Check the appearance of gelatin & other material before use, weigh qualified material correctly
2. Finished melt-gelatin without particle & fine thick air bubbles
3. Control the other requirements of process
Material Preparation Process
The content of monitor for finished preparation
1. When use the material, the appearance & weight should be qualified.
2. The middle product finished preparation should meet the regulation of process.
3. Check as per the items of product standard
Soft-gel Forming process
The monitor content of Soft-gel Forming course
1.Soft-gel Shape: no abnormity capsule, suture is fast & tidy
2. The Thickness of Soft-gel shell:
3. Average dosage & its difference should meet the regulations of Chinese codex or USP29, GB16740
Shaping & Drying
The monitor content of Soft-gel Shaping & Drying course
1. Finished shaping the surface of soft-gel should be clean & no oil remains
2. The moisture & hardness of the soft-gel
The monitor content of Soft-gel Light Inspection course
1. Appearance of the soft-gel: no abnormal capsule, oil leakage, air bubble inside, impurity inside or different in capsule size etc NG capsules
2. Crevice of soft-gel: the suture should be fast & tidy
The monitor content of Soft-gel Inner Package course
1.Correct variety
2. Quantity: should be correct & its deviation within allow scope
3. Air-tight of the inner packing bottle/sachet: should be fast air-tight
Outside Package
The monitor content of Soft-gel Outside Package course
1. Confirm the printing Batch Number, Manufacture Date and Validity is correct, clear & no lost
2. The labeler stuck correctitude & fast
3. The content & quantity is correct without mistakes
Test for finished products
1.In section for Appearance, Disintegration Time & Dosage difference etc
2.Test for normal physical & chemical items: Acid Value, PEROXIDATING Value, Ash Content, Moisture, Nonvolatile Matter and Solvent Remain etc;
3.Heavy Metal: Lead, Arsenic & Mercury etc;
4.Test for Animalcule: Bacteria colony-forming units, mildew, MICROZYME, COLIBACILLUS, SALMONELLA, SHIGELLA, Staphylococcus AUREUS and hemolytic streptococcus;
5. Active ingredient content determine: Method of High Efficiency Liquid Phase Chromatogram, Method of Gaseous Phase Chromatogram, Method of Atom Fluorescence SPECTROPHOTOMETRY, Atom Absorbing SPECTROPHOTOMETRY, Ultraviolet-Sight light SPECTROPHOTOMETRY and Titration.
6. Process testing as per product standard
 2)Control for environment of the clean area
In the clean area sampling from air, walls, ceilings, surface of facilities & human body, judge the whether or not the environment met the expecting requirements.
①Monitor of Animalcule: method of bacteria colony-forming
②Monitor of dust particle quantity: dust particle counting method
③Monitor of personal sanitation: Dish contacting or tampon wiping method
④Monitor of surface Animalcule: tampon wiping method on walls, floors, ceilings & surface of the facilities
 3)The key control station for GMP workshop
Setup Key Control Point of GMP, daily track checking during process GMP implement to promote GMP ideas for operators & improve production environment.
 4)Management for measuring apparatus
①Track the using conditions of all measure apparatus
Check whether or not the operator uses the measure apparatus correctly
Check whether or not the measure apparatus is in correct using condition
②Regularly calibrate measure apparatus, normally QA should calibrate once every two weeks
③Regularly calibrate measure apparatus with green mark and calibration term & organization
 5)Quality analysis for the production process
①Aperiodicity organized relative department to analyze the reason of the quality problem caused in production process, adopt with corresponding correcting measures and track the implement results
②Monthly summarize briefly & analyze on the quality problem caused in production process to reduce the rate of problem caused.
③When received customer claim on quality problem, QA should as per laws/rules issue improving suggestions and initiatively track the improved results.
 6)Finished product release
Before each batch accept into warehouse, it must be pass through QA inspection and input it with qualified certificate.
①Production entire process: meets the regulation
②Production batch record: complete & correct
③Product: qualified by test
3.Laws support
 1)After sales service for product

2)Hold national documents of rules & laws carry out & execute
 3)Standardization
①Setup & perfect the enterprise owned product standard
②Support customer setup their enterprise product standard
③Apply for enterprise product standard
4)Licenses apply, check & certificate update
①Production License for drug
②Sanitation License for health food
③Sanitation License for food
④Sanitation License for cosmetic
⑤Industrial Production License for cosmetic
5)Promote the regulations of trade
①GMP Certificate for drug
②GMP Certificate for Health Food
③BRC Certificate for supplier
④Exportation Product Sanitation Register Certificate
⑤Three Grade of Measuring Guarantee System Qualified Certificate
6)Management for record files

7)Training
①New staff training before operation
②GMP training
③Quality Management training
④Production process training
⑤Sanitation knowledge training
⑥SOP training
⑦Fire-extinguish safety training
⑧Environment Protection training
⑨HACCP training
⑩BRC training
⑾ISO14000 training
⑿Team development training

Process inspection & test for material, semi-products, finished products, environment & water quality, fast & correctly offer tested results as support data for production at-site monitor. The quality testing center with international advance-level equipped with 40units/sets meter & apparatus with regular calibrated & qualified certificate; can fulfill more than 95% of products testing.
1)Physical & Chemical testing
2)Microbe limit testing
3) Apparatus analyzing
4)Heavy metal limit testing
5)Stability testing & watching
6)Water quality testing

Supper High Effective Liquid Phase Chromatogram Meter High Effective Liquid Phase Chromatogram Meter Gaseous Phase Chromatogram Meter (FID)
Gaseous Phase Chromatogram Meter (ECD/FPD) (Hitachi) Atom Absorbing spectrophotometry Atom Fluorescence spectrophotometry
Ultraviolet-Sight light spectrophotometry Automatic Electric Potential Titration

Electronic Balance Scale

(0.01mg)

Electronic Balance Scale

(0.1mg)

Electronic Balance Scale

(1mg)

Low Constant Temperature & Humidity Testing Oven
Strong Light Irradiation Testing Oven for Drug Counter for Dust Particle High-pure Water Filtrated
Dissolution Testing Meter Intelligence Disintegration Testing Meter Melt Time Limit Testing Meter
Microwave Clear-up Meter Automatic Electric-heating Digester Frozen Force Testing Meter
Brabender Viscometer Digital Display Viscometer Color Difference Testing Meter
Color Compare Meter Digital Display Automatic Polari-meter Precision pH Meter
Conductivity Meter Intelligence Scatter-light Transmissometer Abbe Refract-meter
Lustration Working Table Biochemistry Incubator Water Isolation Type Incubator
Dry Trunk with Vacuum & Constant Temperature Digital Display Dry Trunk with Blast & Electric-heating Resistance Type Heating Trunk

1)Physical & Chemical testing
Frozen Force & Viscidity etc
Clarity Grade
Color & Luster
Dosage
pH Value
Relative Density
Viscidity
Impurity
Titration Analyze: Acid Value & PEROXIDATING Value etc
Nutrition Content: Protein & Fat
2)Test for Animalcule
Bacteria colony-forming units
Mildew
MICROZYME
COLIBACILLUS
SALMONELLA

Company Profile

sunever biology company limited

Contact Person: Mrsvicky

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