跳到主要內容區塊

主管法規查詢系統

:::

英譯法規內容

法規名稱(Title) Guidelines of Good Manufacture Practice (GMP)for Veterinary Drugs Manufacturers Ch
公發布日(Date) 2014.10.22
法規沿革(Legislative) 1. Total of 45 Articles were promulgated and taken into force on
June 2, 2006 by Council of Agriculture, Executive Yuan:
Nong-Fun-Tzi 0951472454
2. Article 45-1 was added and promulgated on February 21, 2008
by Council of Agriculture, Executive Yuan: Nong-Fun-Tzi
0971472046.
3. Artilcle 23 was amended and promulgated on October 22, 2014
by Council of Agriculture, Executive Yuan: Nong-Fun-Tzi
1031472991 .
法規內文(Content)

Article 1 
The Guidelines are instituted pursuant to Paragraph 3 of Article
12 of theVeterinary Drugs Control Act.

Article 2 
There shall be premises, facilities and equipments in accordance
with the Establishment Standards of Veterinary Drugs
Manufacturers and the veterinary drugs manufacturer (hereinafter
the Manufacturer) shall conform to the circumstances prescribed
as follows:
1. There shall be the respective clearly written operating
   procedures  for all operations;
2. There shall be operators with adequate training able to
   accurately  perform the duties;
3. Raw material, product containers, seals, labeling material
   and packaging material conforming to the existing
   specifications and storage conditions shall be used;
4. All manufacture processes shall meet to the existing operating
   procedures along with the records of the product manufacture,
   processing, packaging, storage and distribution recorded and
   reserved in a clear and easy-to-evaluate manner sufficient to
   trace the aforesaid matters of each batch to ensure the
   product quantity and quality to conform to the existing
   standards;
5. There shall be a proper system of product storage and
   distribution and the establishment of the rapid recall system
   of sold products.

Article 3
  The terms prescribed in the Guidelines are defined as follows:
1. Drug: denotes the veterinary drugs prescribed in Article 3 of
   the Veterinary Drugs Control Act;
2. Raw material: denotes any substance used in the manufacture
   processof products, including those not included in the final
   product;
3. In process material or intermediate product: denotes any
   product obtained during the manufacture process able to
   become the product via the post manufacture process;
4. Product: denotes that after manufacture process, the active
   pharmaceutical ingredient, or finish product with effective
   ingredients, and they always has in-active ingredients in
   finish product;
5. Labeling: denotes all labels, instructions, package material
   and all of the word and picture with the finish product.
6. Packaging material: denotes the material used to package the
   product excluding the container and seal;
7. Finished product: denotes the veterinary drug with the finished
   packaging operation and the appearance tells the relevant
   information about the contents inside the package;
8. Batch: denotes that follow the same manufacture indications,
   obtained specific quantified drugs or other substances with
   the identical property and quality; as for the consecutive
   process, it denotes
   the specific quantity produced within a certain period or the
   consistent quality within a certain limit;
9. Batch number: the clear words, numbers, symbols or their
   combination attached sufficient to trace the complete
   information of the products or relative substances;
10. Contents: denotes one of the following circumstances:
   (1) The unit quantity of the active ingredient contained in
       the finishproduct;
   (2) The potency of the finish product, i.e. the therapeutic
       effect confirmed by the proper experiments or sufficient
       clinic data;
11. Fiber: denotes the substance with a length 3 times larger
    than the width;
12. Non-fiber liberation filter: denotes the filter that
    prevents the fiber from entering any filtered solution,
    bulk or product by the proper pretreatments such as rinsing
    or flushing;
13. Validation: denotes the action certified by documents which
    can prove that any procedure, manufacture process, machinery,
    bulk, action or system can definitely lead to the expected
    effect;
14. active pharmaceutical ingredient: denotes the pharmacological
    active component or ingredient obtained via the physical or
    chemical treatment or the biotechnical process which may be
    employed to manufacture drugs, biomedicines or biotechnical
    products;
15. Biotechnical product: denotes the product manufactured by
    biotechnological methods such as genetic recombination, cell
    fusion or microbes through cell culture and fermentation
    technology or tissue extract or the active material
    proliferation of embryos or animals. The biotechnical
    products are managed respectively by the reagents of
    veterinary drugs, veterinary biomedicines or veterinary
    diagnosis pursuant to the sources, ingredients and purposes;
16. Biopharmaceutical: denotes the serum, antitoxin, vaccine,
    toxoid, and strain solution manufactured in accordance with
    microbiologic and immunologic theories.

Article 4
The quality control and manufacture departments shall be
independent.

Article 5
There shall be the respective responsible personnel in all
departments of the Manufacturer along with adequate personnel to
execute and supervise the manufacture, processing, packaging or
storage of each product.

Article 6  
The responsible persons, supervisors and employees in all
departments of the Manufacturer shall have the adequate
knowledge and experience, and accept, participate in and
execute the practical training prescribed in the Guidelines.The
staff in aseptic workplaces shall accept the relevant
professional training.

Article 7  
The Manufacturer shall order the written personnel operational
hygiene regulations and include the circumstances as follows:
1. A periodical health examination in compliance with the work
   properties;
2. Set up prevent impact procedure of employees affected by an
   infectious disease or suspected to be affected by an
   infectious disease or with open wounds from affecting the
   safety or quality  of drugs;
3. Regulations that demand sufficient washing or sterilization
   prior to entering the workplaces, and prohibit the actions
   like wearing accessories, eating and drinking, smoking or
   other hindrances to sanitation in the manufacture areas;
4. Standards of the uniforms, caps, masks, gloves, sleeves and
   shoes covers that the employees shall wear in compliance
   with the nature of the workplaces.

Article 8  
The Manufacturer shall order the written detailed operating
procedures concerning the quality standards of raw materials,
product containers or seals and the check on delivery, labeling,
storage, treatment, sampling,inspection and examination
concerned.
The containers packaging starting materials and product
containers or seals shall be marked batch by batch with clear
codes and the statuses of under test, acceptance, rejection or
quarantine required along with the treatment records of the
batches of objects.

Article 9  
The representative sample shall be sampled batch by batch along
with the notation upon the original containers for the stock of
the raw materials and product containers or seals.
The adequate label shall be attached to the container of the
preceding sample to trace the name, batch number, sampling basis
and original container of the sample and the name of the sampler.

Article 10 
The sample prescribed in the preceding Article shall be tested
in compliance with the principles prescribed below:
1. Each raw material shall be tested to ensure the essence,
   purity and strength / contents to conform to meet the
   specifications. However,except for the identification test,
   the test may be exempted by assessing the reliability of the
   test report offered by the supplier;
2. The product containers and seals shall be tested to ensure
   the conformity to the existing specifications;
3. As for raw materials and product containers or seals
   vulnerable to the pollutants, insects, foreign matters or
   microbes leading to the impact on the expected purposes,
   there shall be tested items and methods in the quality
   specifications for the batch-by-batch test.

Article 11  
The raw materials and product containers or seals which conform
to meet the specifications through the test shall be release,
whereas those which fail to meet the specifications shall be
rejection.
The raw materials and product containers or seals with the
acceptance shall be used under the principle “the first
release first use”. Those under the long-term storage, or
exposed to the air, high temperature or other unfavorable
conditions shall be retested.
The raw materials and product containers or seals with the
rejection shall be marked and be quarantined and controlled
prior to proper treatment.

Article 12  
The Manufacturer shall assign qualified personnel to set up the
manufacture batch record of each product for the consistent
quality of each batch along with other personnel to verify
independently. The manufacture batch record in the preceding
Paragraph shall include the following terms:
1. The product name, contents, active contend or dosage form;
2. The name, weight or volume of each effective ingredient
   contained in the product unit weight, volume or dosage form,
   and the total weight or volume per unit dosage form;
3. The name and specifications of all raw materials along with
   the code sufficient to indicate the property;
4. The batch size for each product;
5. The weight or volume required for each raw material. There
   shall be the rational excess and biased range of raw
   materials for manufacturing the preparation. There shall be
   an interpretation in the manufacture batch record;
6. The theoretic weight or volume in the proper stage in the
   manufacture process;
7. The theoretic yield, including the upper and lower limits of
   the theoretic yield percentage;
8. The specification of the product containers, seals and
   packaging materials shall be attached with the label of the
   approver’s name and the date and the sample or copy of other
   markings;
9. The complete instructions of the manufacture and control and
   the procedures, specifications and precautions of sampling
   and testing.

Article 13  
The Manufacturer shall set up the written operating procedures
of the process control which shall be approved by the Quality
Control Department to insure the product property, contents,
quality and purity.The bias between the actual control operation
and the written procedures shall be recorded along with the
rational judgment and illustration.

Article 14  
For each manufacture operation, the container used to manufacture
or storage, production line and key equipment shall be labeled
for manufacture status, time, and date. And record in the
manufacture batch record.

Article 15  
The raw material quantity used for manufacturing operation
shall enable the effective ingredient to remain not less than
the label claim.
The operation of the raw material dispensing and separation
shall be conducted in the specified segregated place with the
proper supervision and control.
There shall be the detailed written test procedures for the
representative sample of each batch of in process product or
intermediate product.
The quality control department shall execute in process control
test on in process products or intermediate products under the
existing test procedures and determine the acceptance or
rejection concerned in the process. The in process products or
intermediate products with the rejection shall be marked and be
quarantined and controlled.

Article 16  
Where the workplace to dispensing, blending, crack, compress,
filling and package the antibiotics powder is shared with the
common workplaces, there shall be a complete confirmation plan
to avoid cross-contamination.
There shall be adequate measures made for the products needless
of sterilization in their written operating procedures to avoid
contamination from the hazardous microbes.
There shall be adequate measures made for the products in need
of sterilization in their written operating procedures,
including the steps to confirm the sterilization validation
result to avoid the microbial contamination.

Article 17  
The in process products or intermediate products should be store
separately; if they are not store separately, there shall be
measures to prevent the contamination and the impact on the
quality.

Article 18  
The storage places for raw materials, in process products,
intermediate products and products and the workplaces for
manufacturing, processing and packaging products shall remain
at the proper temperature and humidity which prevent the quality
reduction except for special workplaces.

Article 19  
The surface of the equipment which contacts directly with raw
materials, in process products, intermediate products or
products shall be made of a material with no property of
reaction, liberation or adsorption.
The objects required by the operations such as lubricant or
coolant may not contact any of raw materials, product
containers, seals, in process products or products.

Article 20  
The equipment and tool used for manufacture, processing,
packaging and storage shall be periodically cleaned and
maintained, and there shall be written operating procedures to
avoid any malfunction or contamination.
The materials of the equipment and tool in the aseptic
workplaces shall be easy to wash, dry and sterilize, and there
shall be periodical washing,sterilization and maintenance to
avoid the impact on the aseptic operation.

Article 21  
The Manufacturer may not employ a fluid filter with the
possibility of fiber liberation without an additionally set
fiber liberation filter as manufacturing, processing and filling
injections.

Article 22  
The automated machinery, electronic devices and computers used
in the manufacture process or the related side software and
equipment of drugs manufacture, manufacture, packaging or
storage shall be periodically calibrated, checked and inspected
under the existing plan and be filed for further maintenance.
The major production and the management records controlled by
the computer system must be maintained and may not be altered
without the authorization of competent personnel. The accuracy
of any input and print of all data shall be checked and the
validation period concerned shall be determined by the
complexity and the reliability of the computer system.

Article 23 
The manufacturer shall implement the following validation
procedures for all drugs. These restrictions do not apply to
those domestic factories and foreign manufacturing factories
which completed the approval of registration before the date of
December 31, 2014:
1. Sterilization Process;
2. Water Systems;
3. Cleaning Validation;
4. Analytical Method;
5. Manufacturing Process;
6. Final Sterilization;
7. Air Conditioning;
8. Computerized Systems;
9. Aseptic manipulation;
The manufacturer may apply for inspection by the competent
authority after completing the validation procedures for all
drugs of the provisions of the preceding paragraph, and then
the competent authority may publish the qualified manufacturing
factories.

Article 24  
There shall be written control operating procedures for the check
on delivery, labeling, storage, management, sampling and test of
packaging and labeling materials which shall be complied with.
The representative sample shall be inspected through batch-by-
batch sampling at the check on delivery of or prior to the
employment of the labeling or packaging materials. The result
shall be recorded and reserved. Those with the conformity to the
existing specifications may be granted the acceptance whereas
those with the inconformity may be granted the rejection.

Article 25 
There shall be individual storage and proper marking for the
labels and other package materials in accordance with the product
categories, strength / contents or dosage forms. It is prohibited
to enter the aforementioned storage area without the agreement
of the competent personnel.
The packaging and labeling materials inapplicable to use or with
the rejection shall be returned or destroyed. The issuance and
utility and the returned quantity of the labeling materials
shall be identical.
The labeling materials printed with the batch number shall be
destroyed immediately if there is any residual; the labeling
materials with no batch number shall be properly examined and
stored to avoid mix-ups.

Article 26  
The accuracy and applicability of the packaging or labeling
materials shall be checked prior to the packaging and labeling
operations. The result concerned shall be record in the
manufacture batch record.
The packaging and labeling equipment shall be checked prior to
the operation to insure the entire removal of the packaging and
labeling materials of the previous drugs and inapplicable to
this operation. The result shall berecord in the manufacture
batch record.The products which go through the packaging and
labeling operations shall be checked in the final operating
process to ensure the accuracy of the labeling of each container
or package.

Article 27  
There shall be an expiration or storage limit confirmed by the
existing stability test marked on the products except for those
prescribed additionally in order to ensure the conformity of the
product ingredients, contents, quality and purity to the
existing standards during the use.
There shall be a clear indication of the formulation method and
the expiration of the unformulated and formulated product if the
product demands the formulation prior to the use.

Article 28 
The Manufacturer shall set up the written product warehouse
operating procedures and include the circumstances as follows:
1. The quarantine procedure before the finish product release ;
2. The storage conditions such as the proper temperature,
   humidity and illumination that prevent the product
   ingredients, strength / contents,quality and purity from any
   impact.

Article 29 
The Manufacturer shall set up the written distribution operating
procedures and include the circumstances as follows:
1. The principle shall be “first manufactured first sold”;
   there    may be temporary and proper adjustment in response
   to the demands;
2. The distribution method that prevents the product ingredients,
   strength/ contents, quality and purity from the impact of the
   bad circumstantial factors;
3. The establishment of a rapid recall system of sold products.

Article 30  
The Manufacture shall set up the written responsibility and
operating procedures for the Quality Control Department and
include the circumstances as follows:
1. In charge of the acceptance and the rejection of all raw
   materials, product containers, seals, in process products or
   intermediate products, packaging materials, labeling
   materials and products along with the examination of the
   manufacture records to ensure no occurrence of any errors or
   the thorough investigation of the errors;
2. In charge of the examination of any operating procedures or
   specifications sufficient to affect the product ingredients,
   strength /contents, quality and purity;
3. There shall be sufficient testing equipments to test and
   examine raw materials, product containers, seals, packaging
   materials, in process products, intermediate products or
   products;
4. The institution of the written operating procedures of the
   calibration of the instruments, devices, meters and recorders
   along with the clear prescription of the calibration methods,
   timetables and limits of precision, and the limited use and
   supplemented measures if inconformity to the precision occurs;
5. The institution of the written operating procedures of the
   sampling quantity, test interval, and test methods relating
   to the product stability meeting the storage conditions in
   the retail market to determine the proper expiration.

Article 31  
Any of the specifications, standard operation procedure,
sampling plans and test method ordered by the departments of the
Manufacturer or the inspection control measures prescribed in
the Guidelines and any alteration concerned shall be executed
through the examination of the Quality Control Department.
The Manufacturer shall comply with the operating regulations
prescribed in the Guidelines and record the executive process.
If there is any bias,there shall be a record and rational
judgment and statements.

Article 32  
The test shall be exercised on each batch of products to ensure
conformity to the existing specifications.
The relevant batch-by-batch test shall be exercised on the
products which shall not contain any microbe if necessary.
As for the batches of products or finished products, and the raw
materials of the effective ingredients, there shall be a
representative reserved sample; moreover, the reserved sample of
the product or finished products shall be kept in conditions
identical with the labels.
The reserved quantity shall be 2 times and more than the demanded
quantity required for all prescribed inspections; however, the
quantity for the aseptic test shall be prescribed in accordance
with the demands The reserved sample shall be kept at least one
year after the expiry date of the product concerned.

Article 33  
The animals used for the testing of raw materials, in process
products, intermediate products or products shall be bred,
maintained and treated in proper ways.
The animals for the experiments shall be marked. The reserved
records shall be sufficient to trace and realize the use process.

Article 34  
The testing shall be exercised on a non-penicillin product to
ensure that there is no contamination of penicillin, hormone,
or cephalosporin drugs.

Article 35 
The records relating to the manufacture, control and distribution
shall be kept for at least 2 years after the expiry date of the
batch of the product or finished product.
The records or the copies concerned, prescribed in the
Guidelines, shall be reserved in the proper place in the
reserved period for random audits exercised by the competent
authority at any time; the auditor may copy or duplicate the
record or the copy concerned in any manner.
The Manufacturer shall exercise the assessment of the product
quality standards at least once annually to determine whether
there is any improvement for the product standards and the
manufacture or control operating procedures based on the records
prescribed in Paragraph 1.

Article 36  
There shall be a manufacture batch record of each batch of
products, and the complete data of the manufacture and control
concerned.
The Manufacturer shall make a precise copy of the manufacture
batch record and check the precision along with the signature
and date noted.
The Manufacturer shall record in detail the key steps of the
processes of manufacture, processing, packaging or storage and
include the circumstances as follows:
1. The date and product batch number;
2. The labeling of raw materials, in process products or
   intermediate products;
3. The identification between the major equipment and production
   lines;
4. The weight and volume of materials used in the processing
   process;
5. The result of the manufacture process and testing result;
6. The pre-use and post-use check of labeling and packaging
   workplaces;
7. The percentage of actual yield and the theoretic yield in the
   proper stage in the manufacture process;
8. The complete labeling control records, including samples or
   copies of all labeling;
9. The labeling and consumption of the product containers and
   seals;
10. The sampling records;
11. The operating date, time, operator and the supervisor’s or
    auditor’s signature and date of the key steps of the
    operating processes.

Article 37  
The test record made by the Manufacturer shall note that whether
the obtained data conforms to the existing specifications, and
include the circumstances prescribed below:
1. The sampling place, quantity, batch number or any other clear
   code,sampling date and the date of checking the sample on
   delivery;
2. The basis of all test methods;
3. The weight or volume of the sample used in the test;
4. The complete records of the data produced in the test process,
   including the graphs and spectra output by instruments, with
   the definite labeling of test raw materials, product
   containers, seals, in process products, intermediate products
   or products and the batch number concerned;
5. All calculate records of the testing operation;
6. The record of the testing result and the judgment via
   comparing it with the existing specification;
7. The testing date and the operator’s name;
8. The verification signed by the auditor of the precision and
   actuality of the original record and the conformity to the
   existing specifications.

Article 38  
The manufacture and quality control records of all products
including the packaging and labeling control records shall be
tested by the Quality Control Department to ensure the
conformity of the products to the existing written operating
procedures prior to the release or distribution.
A thorough investigation shall be exercised on the batch of
product whether it is sold or not if the percentage of the
theoretic yield exceeds the maximal or minimal percentage
prescribed by the manufacture control standard manual or there
is any unexplained difference, or there is any inconformity of
products or materials.
The investigation shall extend to the identical products of
other batches or other products relating to the difference
concerned.
The investigation in the preceding Paragraph shall be recorded
in written form and shall include the conclusion and treatments.

Article 39  
The distribution record shall include the product name,
strength /contents, dosage form, batch number, the receiver’s
name and address,shipped date and quantity.

Article 40  
The written record of each complaint shall be reserved in the
product complaint file which shall be kept in proper places or
other facilities available to the audit at any time.
A written record shall be kept for 2 years after the expiry date
of the complained product or 2 years after receiving the
complaint; the longer period shall be the standard.

Article 41  
The record of the returned product shall include the name,
strength /contents, batch number, reason, quantity, treatment
date and the final treatment method. The record shall be kept
in compliance with the provision prescribed in Article 35.

Article 42 
The Manufacturer shall order the written treatment operating
procedures for written or oral complaints from customers. The
Quality Control Department shall exercise the examination and
confirmation of all written or oral claims.
Any apparently severe and unexpected product defect shall be
reported to the respective relevant competent authorities and
treated in compliance with the related provisions in the
Veterinary Drugs Control Act.
There shall be written records of the treatment of all
complaints along with collation and filing as the references
to the quality assessment of the product concerned.

Article 43  
The returned product shall be examined and stored separately.
The Manufacturer shall destroy the product if there is any
doubt of the product safety, ingredients, strength / contents,
quality or purity due to storage and transport conditions prior
to the return or in the return process or the product, container,
packaging, labeling or other situations where the safety,
ingredients, strength / contents, quality or purity fails to
conform to the existing specifications through inspection or
investigation.
The reprocessing may be conducted if the product can conform to
the existing specifications through the reprocessing.

Article 44  
The veterinary raw materials manufacturer shall manufacture the
veterinary starting materials pursuant to the Guidelines. The
enforced items, methods, schedule, standards and other
compliances concerned shall be ordered by the central competent
authority.

Article 45  
The competent authority may exercise the check and assessment
on the Manufacturer. The operating methods of the check,
assessment and severe defects shall be ordered by the central
competent authority.

Article 45-1 
The central competent authority is in charge of the veterinary
drugs inspection registration or the imported veterinary drugs
license extension.Where it is necessary to check the foreign
veterinary manufacturers, the fees follow the precedent of the
foreign errands travel fee which the applicant bears.

Article 46  
The Guidelines shall come into force on the date of the
promulgation.