••

Scopes:
Pharmaceutical Drugs, OTC & Vitamins, Bio-Technology, Herbal, Traditional Medicine, Homeopathic products, Veterinary medicines & Cosmetics

 

Our services covered the following activities:

Product Registration

GMP Designing of Plant (Manufacturing facilities)

Designing of Water System

Site Supervision

Process Control

Validation & Qualification

Internal Audit (Self-audit)

Vendor Evaluation / Rating program

GMP Training

Technology Sourcing / Local Fabrication

 

Activities 1 : Product Registration (Poison, OTC, Trad. Med., Cosmetics)

Documentation of Annexes required and online submission with DCA

Assisting in preparation of product labels and packaging

Assisting in preparation of dossiers for overseas registration

 

Activities 2 : GMP Designing of Manufacturing Facilities

Provide assistance and advice on designing of manufacturing plants of non-sterile and sterile pharmaceutical productions, traditional medicines, as well as cosmetics.
Activities includes:

Conceptual designing (layout) of plant

Process, materials, finished goods & personnel flow

Mechanical & electrical (M&E) requirements (e.g. air quality, water and power requirement)

Provide input for suitable materials for construction

Designing of water system such as DI, RO or WFI, inclusive of required piping system

Providing assistance in selection and sourcing of required equipment

Design for a suitable utility system e.g. HVAC, compressed air, steam, de-dusting

 

Other related activities :

GMP Consultation to manufacturing plant

As a visiting consultant (on a retainer basis)

Through periodic inspection, identify GMP weakness or defects and propose corrective actions

Providing technical input in corrective and preventive actions

Training needs analysis

Preparation of a Site Master File and Validation Master File for new or existing plant

Provide input for a suitable waste water treatment system

Development of a suitable quality (GMP) system and the relevant documentation.

 

Activities 3 : Designing Water System

Designing of water system for Purified Water or Water For Injection as per BP or USP

Reviewing (audit) of water system

Designing of water piping (loop system)

Provide consultancy to procurement of water system

 

 

Activities 4 : Site Supervision of Factory Construction

Provide expertise in supervision and follow-up of the design specifications

Ensure compliance to structural design specs and M&E specs by contractors

Helps to liaise with Engineering consultants on rectifying defects detrimental to GMP

 

Activities 5 : Process Control

Provide training with regards to all aspects of manufacturing processes

Review (audit) of current manufacturing processes

Consultation on development, improvement and trouble-shoot of manufacturing processes

 

Activities 6 : Qualification & Validation

Provide assistance and expertise in carrying out qualification & validation program, which includes DQ/IQ/OQ/PQ of equipment, facilities and utilities, as well as process validation such as blending process, capsulation, tableting and aseptic media fill.

Provide assistance and expertise in carrying out Cleaning Validation

 

Activities 7 : GMP Audit

Provide resources and expertise for conducting an in-house GMP Audit.

Identifying defects and weakness

Proposing corrective action plans

 

Activities 8 : Vendor Evaluation Program

Provide assistance and expertise in carrying out a program to evaluate vendors or suppliers. This program is vital in GMP to ensure quality of materials supplied is consistently to the standards set.

 

Activities 9 : GMP Training

Provide training with regards to all aspects of GMP, from basic concept in understanding of quality to documentation, process control and validation. See our available training modules.

Training conducted can be in-house or at our training centre and be specially tailored for your needs.

 

Activities 10 : Technology Sourcing / Local Fabrication

Provide input and assistance in sourcing and procurement of suitable new equipment and/or technology

Provide information on fabrication work and helps identify suitable fabricator

Provide services in preparing of a User requirement specifications (URS) for submission to potential supplier / fabricator

 

 

Privacy Policy | Terms of Use | Sitemap

A1 Consultancy & Integrated Services Sdn Bhd 2006 Designed by Web Channel PROductions.