Consultant for GMP, Regulatory affairs, Product Registration covering Pharmaceuticals, OTC, Health Supplements, Traditional and especially Cosmetic Products Notification.
We offer advisory, consultancy and monitoring services for product registration with Drug Control Authority; NPCB (National Pharmaceutical Control Bureau) covering product range from Pharmaceuticals, OTC, Supplements, Traditional(including Homeopathy) to Veterinary products.
Job scopes covering application of Digital Certificate Membership, evaluating data/document versusDRUG REGISTRATION GUIDANCE DOCUMENT, assist in documents compilation, submission of data required, follow-up, dealing with correspondences from NPCB evaluators and other related issues.
Our experience in manufacturing and keen knowledge of product registration with Malaysia’s local authority (NPCB) will be able to reduce your time factor tremendously. Being able to submit data right at the first time, will be less correspondences during the evaluation process and lead to quicker approval.
Starting 1 Jan 2008, all cosmetic products are to be notified with NPCB (National Pharmaceutical Control Bureau ) by the company or person responsible for placing the product in the market. It is an offence for anyone to manufacture or import a cosmetic product without prior notification to NPCB.
We are here to assist you in getting your product Notification Note within a short period and with a very competitive fee. Job scopes covering evaluating product formula versus Guidelines for Control of Cosmetic Products in Malaysia and assist in preparing other related documents for product notification.
PIF (Product Information File) is a set of document covering technical, certificates, safety information and other related data pertaining to the product as required in ASEAN Cosmetic Directive and should be made readily accessible for inspection by the cosmetic regulatory authority. The company or person placing the product in the market shall be responsible for providing this PIF when requested by NPCB.
Understanding technical terms and data required as per stated in the guideline is not an easy job. Hence with our experience, we will be able to assist you in compiling, evaluating and arranging data information in a manner easy for retrieving whenever needed.
03 Licenses Application
In this industry, you may have to apply licenses from our local authority. We do have the expertise in dealing with all these license application:
Manufacturing License application & re-newels
Distribution License application
Import /Wholesale License
Application of product Certificate of Free Sales
Application for change of manufacturing site
Amendment of product registration certificates
Approval for the advertisement application from Medicine Advertisement Board (KKLIU no)
04 Regulatory Affairs & Other related jobs
We are able to extend our services in dealing with regulation related issues; as per listed below:
Review of product formula (herbal & cosmetics)
Review of product formula for health supplements
Product classification
Evaluation of a product label /outer-box and/or leaflet
Evaluation of store for GSP/Import license application
Application or renewal of smartcard
05 GMP, GDP consultation for manufacturing plant
The main task of the Authority is to ensure the safety, quality and efficacy of pharmaceuticals, health, traditional, veterinary and personal care products that are marketed in Malaysia. Hence in achieving this objective, premises for importer, manufacturer and wholesaler are to be licensed.
With our experience in manufacturing plant & product registration over the years will be able to offer you assistance in maintaining GMP compliance via providing technical input in CAPA and as visiting consultant on a retainer basis. Through periodic visits, we will be able to understand your system and propose corrective actions on identified GMP weaknesses.
06 GMP trainings
GMP is by far the most effective tool for assuring safe, quality and efficacy production of pharma products (which include pharmaceuticals, health, traditional, cosmetic and veterinary). Under the regulatory guidelines for manufacturing, it stated clearly the needs of regular and continuous training to be provided to personnel in ensuring they will be aware of the principles of Good Manufacturing Practice in carrying their routine daily jobs.
Most training providers offer training programs or modules to cater the higher level of key personnel and management team training needs.
To fill in the gap, we offer you 8 standard modules of GMP training to educate the supporting key personnel(junior executives, supervisors, line leaders, operators) in ensuring they too do get the message across and will be able to carry their responsibilities. Our available standard modules are:
M1-Basic GMP
M2-Basic Documentation
M3-Basic Hygiene
M4-Control & Handling of materials
M5-Packaging process
M6-IPQC & Area Clearance
M7-Internal Audit
M8-Good Distribution Practice (Covering Good Storage Practice)
All these training are arranged as in-house training, hence will benefit more personnel. For subjects other than the above, we can tailor made to suit your needs.
07 GMP/Quality audit & vendor evaluation
Self inspection should be conducted to monitor the compliance with GMP principles and to be done at intervals following a pre-arranged program.
With years of experience in manufacturing plant and consultation we are able to deliver a thorough in-house GMP Audit. At the end of the process, you will come to know the defects and weaknesses to rectify. We will also proposing corrective action plans.
Vendor evaluation is one of the basic elements in achieving quality products. Ensuring a quality product begins from the level of materials supply by chosen vendors. Hence, by evaluating their level of quality understanding will give you assurance that the quality of materials supplied is consistently to the standards set.
08 Basic GMP Documentation
Good Documentation system is an essential part of Quality assurance program. Having clearly and legibility of documentation prevents errors from spoken communication and allow traceability of a batch history.
We provide consultation services for the development of a basic GMP documentation system for manufacturing operation in compliance to current operation needs and GMP. Job scopes covering assisting you in preparation of Site Master File (SMF), developing a GMP document control system, job description, general SOPs for production operation, QA activities, Maintenance, Store etc. We also will be able to assist in developing a set of Batch Manufacturing Master Records and other required monitoring records such as In-process Quality control, Environmental records etc.
Other than the above, we do provide services in preparing documentation for Qualification & Validation, contract agreement between the manufacturer and the contract giver or with the contract laboratory from GMP aspects point of view. If you do need such services, it will be tailor made to suit your requirements.
09 Other Services/ Technical sourcing
Being in this line of services, we come across associates who will be able to provide you required services in their line of expertise. If you are looking for the services listed below; please do not hesitate to contact us.
