In order to gain more scientific validation for the traditional oriental herbs, Len Fa always put the customer in the front-line, care on the customer opinion, which we running the research and development (R&D). Len Fa do all the best to the in customers' healthcare needs to enhance the quality of everyone life. Placing emphasis on our core values of INTEGRITY, QUALITY and SERVICE.
Under the 'Control of Drugs Cosmetics Regulation 1984' compliance with Good Manufaturing Practice (GMP) is required as one of the conditions to be considered in the evaluation of applications for a Manufacturing License.
Manufacture as defined in the Regulations includes:
(a) the making or assembling of the product,
(b) the enclosing or packing of the product in any container in a form suitable for administration or application, and the labeling of the container, and
(c) the carrying out of any process in the course of any of the foregoing activities.
In the manufacture of traditional medicines that require registration under the Phase III of the product registration exercise, overall control is essential to ensure that the consumer receives medicines of high quality. Haphazard operations cannot be permitted in the manufacture of materials that may be necessary to restore or to preserve health. The good practices outlined in these guidelines should be considered as general guides; whenever necessary, they may be adapted to meet individual needs, provided the established standards of medicine quality are still achieved.
The production of traditional medicines utilizes material of natural origin such as plants, and animals; thus they may be prone to contamination, deterioration and varation in quality. Therefore, the control of the starting materials, storage and processing of traditional medicines is important. The control is also required because of the often complex and variable nature, the number and the small quantity of defined active materials in many traditional medicines.
The manufacture of traditional medicines depends on the starting materials, manufacturing processes, building , equipment and personnel involved. It is not sufficient that the finished product passes testing protocols, but quality must be built into the product. All traditional medicines should be manufactured under carefully controlled and monitored conditions, and sole reliance should not be placed on any test for assurance of the quality of the end product.
The purpose of these guidelines is to outline steps which should be taken, as necessary and appropriate, by manufactures of traditional medicines with the oblective of ensuring that their products are of the nature and quality intended.
Good Manufacturing Practice for Traditional Medicinal
Product
Good Manufacturing Practice is that part of Quality
Assurance which ensures that products are consistently produced and controlled
to the quality standards appropriate to their intended use and as required by
the Product Registration or product specification.
Good Manufacturing Practice (GMP) license had been certified by the Ministry of Health to all the manufacturter that achieve the sudden level of the production in it own manufacturer.
The Malaysian Standard describes requirements for food safety according to hazard analysis and critical control point (HACCP) system.
There are several considerations which should be discussed before proceeding to sectors where significant, scientifically proven, public health risks are associated with a particular food product or processing method. While HACCP should be voluntarily adopted thoughout the food industry, HACCP need not be mandated for all products or industry sectors. Risk , along with the safety history of a particular food, must be used as the primary means of determining which food industry segments should be required to develop and implement HACCP plans. The need for HACCP should be decided by expert panels who would consider whether food safety hazards of public health significance are associated with a particular food industry segment. The risk assessment exercise should be a cooperative effort between both the public and private sectors and not the sole province of government bodies.
HACCP is not a stand alone system. It depends on management commitment and a solid foundation of prerequisite programs such as GMP. HACCP is not intended to replace these programmes, nor to diminish their significance. For HACCP to be effective, these prerequisite programmes must be in place. Before considering a safety management system such as HACCP, it is advisable to determine if a particular industry segment is ready to build upon existing programmes, or whether attention must first be focused on basic hygienic practices.
HACCP system
HACCP shall mean a system which identifies, evaluates,
and controls hazard which are significant for food safety. The system consists
of seven principle
Priciple 1
Conduct hazard analysis to identify
the potential hazard(s) associated with food production at al stages, from primary
production, processing, manufacture and distribution, untilo the point of consumption.
Assess the likelihood of occurrence of the hazard(s) and identify the control
measures.
Priciple 2
Determine the points/ procedures/ operational
strps that can be controlled to eliminate the hazard(s) or minimize its likelihood
of occurance as a CCP.
Priciple 3
Establish critical limiy(s) which must be
met to ensure the CCP is under control.
Priciple 4
Establish a system to monitor control of the CCP
by scheduled testing and/ or observations.
Priciple 5
Establish the corrective action to be taken when
monitoring indicates that a particular CCP is not under control.
Priciple 6
Establish procedures for verification which inculde
supplementary tests and procedures to confirm that the HACCP system is working
effectively.
Priciple 7
Establish documentation for all procedures and records
appropriates to these priciples and their application.
The International Standard specifies requirements for a quality management system where an organization needs to demostrate is ability to consistently provide product that meets customer and applicable regulatory requirements and aims to enhance customer satisfacation through the effective application of the system, including processes for continual improvement of the system and the assurance of the confirmity to customer and applicable regulatory requirements.
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.
For the purposes of this Internation Standard, the terms and definitions given in ISO 9000 apply. The following terms, used in this edition of ISO 9001 to desribe the supply chain, have been changed to reflect the vocabulary currently used:
Supplier ————› Organization ————› Customer
The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refer to the until to wish this International Standard applies. Also, the term “supplies” now replaces the term “subcontractor”. Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.
This is important that to let you know one of the most successful on the Len Fa Medical Supplies did in the year 1998.
Len Fa had successully been record down in THE MALAYSIA BOOK OF RECORDS as the FIRST PRODUCER OF ESSENCE OF OSTRICH in Malaysia since July, 1988.
Len Fa will not stop at one point, Len Fa will continue to produces the new products, for the good health of everyone life.
For the assurance of all Muslim consumers, we also provided the halal products, Len Fa Medical Supplies has been certified by the Ministry of Health and accredited with a HALAL Certificate.
In order to let the people (non-muslim) knows
what is the meaning of HALAL products. Muslim only can take the food which have
a Halal logo
. the
Halal means the the foods excusive all park of pig, dog and some sort of of
the animals.
Len Fa is the trading company since 1967, and the years has pass, Len Fa become one of the biggest manufacturer which manufacturing the traditional medicine and the healthy medicine. Len Fa produces a lot of the product with different brands, this is because understand that different level of people have difference needs.
Nowadays, Len Fa also produces the product in name of CAMBEYN. Camberyn is the new and the only products that cover up all the categories Len Fa has produce in the past. In the future Len Fa will focus more on the brands of Camberyn in the market. Len Fa also hope Camberyn will become the only Len Fa home branded.