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**** Injection for my company research and development of new drugs varieties. To demonstrate the variety of its prescription and technology can produce products that meet corporate standards, I am in the air purification system, water system and equipment revalidation qualified and instruments by test within the validity period, participants trained and passing the examination, basic cleanliness level meet the requirements of this product on a process to verify the whole process. The entire process of pre-production process including the identification of relevant documents, confirming raw materials suppliers of materials, preparation, bottle washing, filling and sealing, sterilization, inspection lights and other production operations practice, and the product to stay kind study to determine stability of the product.
In order to ensure that the product formulation, stability and reproducibility of the process, the production equipment using the same three batches. 2. Authentication purposes
The entire process by verifying process, the text proved by the production process of the prepared product is in line with predetermined specifications and quality standards, to ensure the production of stable quality products. 3. Verify the organization and responsibilities
The company was founded by vice president of production headed to the department heads and all stakeholders workshop director and as a member of the product process validation teams to "**** injection process planning" as the basis, according to "**** injection process validation protocols "for product verification. 3.1 verification team responsibilities:
4. Verify plans and arrangements
It is validated by a date to date. 5. Verify Before You Go
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in conclusion:
Checker: Date of inspection:
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in conclusion:
Checker: Date of inspection:
in conclusion:
Checker: Date of inspection:
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in conclusion:
Checker: Date of inspection:
Checker: Date of inspection:
Checker: Check the date: 6, product names and prescriptions 6.1 Product Name: Injection **** 6.2 Specifications: * ml: ** mg 6
7. Verify embodiment
Flow chart:
7.1 preparation process verification
7.1.1 before production on cleared, check to make sure cleanliness
7.1.2 Materials used name, batch number, lot number picking a case record form:
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7.1.3 filter integrity test (bubble point test) methods, test criteria and the record table 7.1.3.1 Test Methods: "Bubble Point Test protocol" first cartridge loaded process water for injection 7.1.3.1.1 soak for 10 minutes. 7.1.3.1.2 pneumatic connections:
(1) The need to connect gas line in Figure 1.
(2) to close the valve V1, V2, V4 and V5, open the valve V3.
(3) have to carry out the leak detection filter housing before the test, when the valves closed is detected by function 6 can be used for air-tightness test.
(4) The air pressure is adjusted to slightly above the test pressure 0.2MPa. Control 30s, air bubbles were observed at the filter. For example, the barrel and the connection is not tight O-ring is mounted or not the cartridge is fully saturated, then continuous bubbles appear,
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In this case all connections should be checked or replaced O-ring or re-impregnated filter.
(5) absence of bubbles, continuous compression until a continuous or stabilizing gas bubbles were observed to occur in a beaker, then the pressure is the minimum display instrument bubble point pressure.
7.1.3. Criteria 2
The minimum bubble point pressure: 0.22um ≥0.26 MPa, water for injection 0.45um ≥0.18 MPa, water for injection
7.1.3.3 test results are reported in Table
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7.1.4 Process
Stir liquid verifier 7.1.5
7.1.5.1 verification method: the end of liquid feed, after adding water for injection to the total amount, stirring the liquid min, min, min PH value detected liquid were sampled at the sampling port adjusting tank content. 7.1.5.2 validation criteria:
Evaluation of the results:
Evaluation: Date: Approved by: Date: 7.1.6 7.1.6.1 liquid filtration system to verify the authentication method:
Before and after filtration of the liquid chemical trait, PH value, the content of related substances, microbial limits, sterile, projects visible foreign matter detection, validation and liquid filtration systems, and chemical compatibility with the filtration system proved to achieve sterilization filtering effect.
Liquid PH value measurement method: Take liquid stirring ml, with a pH meter uniformly detection result should meet
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Provisions.
Chemical Determination Method: Stir chemical ml, detected by semi **** Injection quality standards, the results should be specified.
For determination of chemical substances: liquid take Stir ml, detected by the injection **** product quality standards, the results should be specified.
Visible foreign matter: when the liquid through the fine filter cartridge um reflux for 5 minutes, then take a flask 100ml, CM-1 in the check type detector clarity, and white point fibers can not be detected.
Microbial Limit Detection Method: liquid before filtration 100ml, detected by the detection limit of the microorganism. Sterility Testing Methods: filtered liquid 100ml, sterility test according to the detection method of the present project, the finished product, the results of compliance.
7.1.6.3 validation results
7.1.6.3.1 Liquid filter before the detection result
Evaluation of the results:
Evaluation: Date: Approved by: Date: 7.1.7 liquid formulated from the beginning to the end of the preparation time of confirmation
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7.1.8 begin to filter sterilization filter to confirm completion time
7.2 ampoule washing procedure verifies
7.2.3 Cleaning process: → ampoule circulating purified water (2 times) → washing → drying water for injection sperm injection parameters 7.2.4 Water temperature: purified water temperature: pressure control: Compressed air pressure: Host Frequency:
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Network with frequency: drying temperature: drying time:
7.2.6.1 Cleanliness inspection
(1) Visual inspection: An inside and outside the bottle should be clean, clear, anhydrous.
(2) taking poured into 200 ampoules fine chemical examination visible foreign matter was filtered off, visible foreign matter should be limited to one. 7.2.6.2 Microbial Limit Test
After cleaning and sterilizing the ampoule according to the 2010 edition of microbial limits test examination, the results should be
After cleaning and sterilizing the ampoule 2010 edition by bacterial endotoxin inspection results should be <0 .25eu="" 7.2.7="" font="" ml="" verification="">
Evaluation of the results:
Evaluation: Date: Approved by: Date: 7.3 potting process verification
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7.3.2 Method validation: Properties of drug, pH, related substances, the content of visible foreign matter, sealing quality, microbial limits controlled by the potting process, to ensure product quality.
Sealing quality: Each casting machine inspection of drugs from each of 100, no stains sealed clean appearance, no blistering, without pores, the focus head, smooth, flat, etc., to meet the requirements length, should be greater than 98% pass rate.
Visible foreign matter: potting beginning, middle, near the end of each machine when 40 samples were obtained drugs foreign matter inspection, the foreign matter 40 can be seen in not more than one visible *** branched.
Microbial Limit Test: the beginning of potting, potting middle stage and end stage depicting good potting drugs *** branch, microbial limit test examination according to the 2010 edition, the results should be <*** CFU / 100ml. Bacteria resistant test: Take the remaining liquid microbial limit test, with *** um membrane filter (filter sterilized 5% Tween sufficiently wetted). This membrane was transferred into a test tube containing 10ml of sterile 0.1% peptone aqueous solution and boiled *** min on a boiling water bath, and then cultured at 30 ~ 35 ℃ days thioglycollate broth, observing whether bacteria growth. 7.3.3 Compressed air pressure conditions:
Mpa 7.3.5 validation results
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Evaluation: Date: Approved by: Date: 7.4 sterilization process challenge
7.4.1 verify clearance before, check to make sure cleanliness
7.4.2 criteria:
7.4.4 Method validation: 7.4.4.1 conditions
Sterilization temperature: Time: Pressure Sterilization: 7.4.4.2 sterilization process *******************
7.4.4.3 sterility test and verification method related substances: sterile hottest spot checks and validation of related substances:
Sterility test specimen sampling: After sterilization, the method in accordance with the provisions of the coldest spot sterilizer and initial filling, final random filling out 50, according to two methods "Chinese Pharmacopoeia" 2010 edition do sterility test should be Compliance.
Related substances Sampling: Samples were taken from each pot at the hottest point sterile, individually packaged and marked evacuation central laboratory after sampling, by injection vinpocetine product quality inspection method under a predetermined standard related substances. 7.4.5 authentication result: a lot number:
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Evaluation: Date: Examination: Date: light inspection step verification 7.5
7.5.1 before verification of clearance, cleanliness inspection
7.5.2 CM-1 light detecting means
(1) source: illuminance LX (2) Shape: Umbrella shed type apparatus.
(3) Background: non-reflective black and white. (4) Distance: test human eye distance of 20 ~ 25cm. (5) check: should be indoors or in dark shadows.
(6) Check the art: vision subject light (not including vision correction) distance and near vision test are 5.0 or 5.0 (i.e. 1.0 or 1.0) or more. There should be no color blindness. 7.5.2.1 inspection methods
The test shown with the gripping support, ampoules wipe blot outer wall, the edge of the shelf in the umbrella, so that liquid gentle inversion, with
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Eye view.
7.5.3 intelligent automatic light inspection machine: the machine parameters, the binary threshold level of the center line, the level variation.
7.5.4 criteria
Press the "Chinese Pharmacopoeia" 2010 edition two visible foreign matter inspection method to determine the results should be consistent with the evaluation results:
Evaluation: Date: Approved by: Date:
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Deviation analysis results:
Analysis: Date: Approved by: Date:
Result analysis:
7.8 sample observation
In order to investigate the stability of the product quality, our company for verification of three batches of the product to stay kind of investigation, the present experiment still in progress. 8. Deviations processing
Should be strictly in accordance with the design inspection and verification process to determine, verify does not affect the quality of the final product, in line with the deviation within the allowable range, there are processed according to the following procedure when the individual projects do not meet the requirements: written and variance analysis.
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8.1 Any deviations from the production process, material balance limits, quality standards, test methods, procedures, etc. are to be recorded and immediately reported to the competent personnel and quality management department, should have clearly stated, significant deviations shall, together with the quality control department other departments to conduct a thorough investigation and a survey report. Deviation investigation report should be reviewed and signed by the designated officer quality management.
8.2 If the reasons for equipment, systems genus, should be reported to verify a leading group for systems and equipment for processing.
9. Verify that the results of the review and verification report
Once verified, the verification team responsible for the preparation of the verification report, shall be evaluated, countersigned members, final approval by the Qualified Person.
Validation Report
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10. Verify the certificate
After verification report approved by the Qualified Person who signed the authentication certificate.
Verification certificate
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