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What is coming? Are you ready for the next FDA and Health Canada inspection?Are you  submitting  new dossier to FDA or Health Canada?

June22, 2018

Elemental Impurities Implementation FDA and Health Canada


Changes to conditions established in approved ANDAs and NDA need to meet PDE recommendations of Q3D or comply with USP <232> PDEs.

On January 1, 2018, new
guidelines regarding elemental impurities in brand and generic drug products went into effect. Elemental impurities, such as arsenic and lead, pose toxicological risks to patients without providing any therapeutic benefit.
These impurities may be present in drug products from a variety of sources, such as interactions with equipment during the drug manufacturing process.

As of January 1, 2018:
All new and existing NDAs and ANDAs for drug products with an official USP monograph are
required to meet the requirements in USP General Chapters <232> and
<233> for the control of elemental impurities. Applicants
submitting NDAs and ANDAs for drug products without a USP monograph are expected to follow

Health Canada

Implementation of elemental impurity risk assessments for new submissions for drug products (ANDS or NDS, S(A)NDS and DIN Applications):

Submissions received by Health Canada after December 31, 2016 should include a risk assessment for elemental impurities. Submissions received after December 31, 2016 that do not have a risk assessment will be requested to submit the missing information.

Risk assessments will be evaluated during the assessment process. The scope of the risk assessment to be submitted for assessment should be based on the principles outlined in the ICH Q3D guideline and related training materials being developed by the ICH Q3D Implementation Working Group. Case studies are currently under development and will be published on the ICH website, when available. Detailed risk assessments and data supporting these risk assessments should be documented and available upon request by the Regulator (e.g., at the inspection stage).

The locations where the elemental impurities-related information can be found in Module 3 should be clearly summarized in Module 2.3.P.5: Control of Drug Product of the Quality Overall Summary.  The overall risk assessment summary for elemental impurities should be placed in Module 3.2.P.5.6 Justification of Specifications. The location of the overall risk assessment summary is currently under discussion by international regulatory authorities. The risk assessment for the container closure system may be cross-referenced to a master file. If toxicology data is submitted to support limits above the ICH Q3C Permitted Daily Exposure or for routes of administration not covered by ICH Q3D, it should be placed in Module Other Toxicity Studies: Impurities.

Compliance with the ICH Q3D guideline should be documented after the risk assessment has been completed and any necessary controls have been implemented. For example, a statement confirming ICH Q3D compliance should be included on the drug product specifications and reflected in the updated Certified Product Information Document (CPID). Additional evidence of compliance should be available on request.

Implementation of elemental impurity risk assessments for Canadian marketed drug products:

S(A)NDSs or Post-DIN Changes for any quality related major change to a drug product (i.e. a new formulation, new drug product manufacturing site, new dosage form) submitted after December 31, 2016 should include a risk assessment for elemental impurities to allow for review and authorization of the S(A)NDS or Post-DIN changes by January 1, 2018. A risk assessment should be performed in accordance with the ICH Q3D guideline and any training materials published as a result of work currently being done by the ICH Q3D implementation working group. Case studies are currently under development and will be published on the ICH website, when available. The risk assessment should be documented and available for inspection and any controls should be implemented, if applicable, by January 1, 2018.


PharmEng Announces Opening of Denver Colorado Office

April 20, 2016

PharmEng Technology Inc. is pleased to announce the official opening of our Denver office which will support the biotech, pharmaceutical, and medical device companies in the Rocky Mountain Region, USA. The Denver location provides cost-effective and convenient access for PharmEng to serve Colorado, Nebraska, Utah, Wyoming, Montana, Arizona and the surrounding areas. The Denver office compliments our existing offices in Atlanta and Boston.

"Our cGMP consulting services has grown significantly in the USA and we are committed to expand our scope of services and geographical locations to better serve our customers" explains Alan Kwong, CEO of PharmEng Technology Inc.

About PharmEng Technology Inc.

PharmEng Technology Inc. is a full-service cGMP consulting company that serves the biotech, pharmaceutical and the life science industries in North America and internationally. Our cGMP compliant consulting services include project management, engineering, commissioning, validation, quality assurance and regulatory affairs.

For more inquiries, please contact This email address is being protected from spambots. You need JavaScript enabled to view it. or Toll free 855.937.9497


PharmEng Technology and Horizon, Pharmaceutial Consultants, Announce Partnership

Dec. 15, 2014

PE and Horizon

PharmEng Technology and Horizon (HWT Engineering Ltd.) today jointly announced that they will enter into a collaborative agreement to provide a range of consultancy services to the Pharmaceutical industry worldwide. This arrangement will see both PharmEng and Horizon take advantage of their excellent positioning in North America and Europe respectively by enabling this partnership the ability to efficiently and effectively deliver a suite of services to their clients requiring expertise in Pharmaceutical Engineering, Quality and Validation.

PharmEng Technology CEO, Alan Kwong, said at today’s announcement, ‘I am excited by this partnership which provides a global platform with combined resources to ensure first class service to our worldwide clients.’

PharmEng Technology is a global Pharmaceutical compliance consulting firm with projects around the world providing quality services to the manufacturers of health care products for over 15 years. PharmEng Technology is a cGMP compliant leader in commissioning and qualification, validation, quality systems, regulatory affairs, engineering, auditing, process development, technology transfer, serialization and training.

Horizon is an award winning global specialist engineering consultancy that provides solutions to manufacturing organisations primarily in the areas of Medical Device, Pharmaceutical and Bio- Technology. Horizon’s offerings are across 3 key operations, Resourcing, Engineering & Development and New Product Development. With a diverse client base across Europe and the US, Horizon provides engineering services to over 50% of the top global life science companies.

Aiden Corcoran CEO of Horizon, said of the Partnership, ‘I’m really excited to be partnering with PharmEng. Together we can offer greater depth in terms of specialist skill supply to both the European and North American regions.’

For more information, please contact This email address is being protected from spambots. You need JavaScript enabled to view it. or This email address is being protected from spambots. You need JavaScript enabled to view it.This email address is being protected from spambots. You need JavaScript enabled to view it.">


cGMP Compliance Audit: 5 Questions You Should Ask Yourself

Jan 5, 2015

procedures-206x103PharmEng Technology published an article written by one of their Senior Consultants, Dr. Peter Chan. Dr. Chan is a senior quality compliance specialist with 16 years of diversified experience in project management, quality assurance, quality control, validation, regulatory compliance and pharmaceutical manufacturing.

The article, entailing detailed information on cGMP Compliance Audits, can be found here or at


PharmEng Technology Is Your Leading Serialization Expert

May 5, 2014

PharmEng Technology has been awarded a significant multi-site serialization project with a multinational Biopharmaceutical company. Our subject matter experts can ensure that you are compliant with the new serialization requirements that will take effect in 2015. Please contact us at 416-385-3922 ext 103 if you are in need of support.


We Understand The East And The West - Business Elite Canada

April  2014

PharmEng Technology is so excited to have been part of the April 2014 issue of the Business Elite Canada magazine. The author, Mudeeha Yousaf, interviewed Alan Kwong, CEO of PharmEng Technology, to determine what sets us apart from other companies in our industry and how we have succeeded over the years. Please find out 6 pages spread titled "We Understand The East And The West" here

PharmEng Receives Recertification For ISO 9001:2008

April 14, 2014

PharmEng Technology has been recertified with the International Organization for Standardization. This certification ensures that we operate a quality management system which complies with the requirements of ISO 9001:2008. ISO helps to harmonize technical specifications of products and services making our operations as efficient as possible, which increases productivity and allows us to provide the most cost effective service to our clients.

Pharmaceutical Regulatory Summit Asia in Beijing, China

March 25-28, 2014

PharmEng Technology will be attending the Pharmaceutical Regulatory Summit Asia in Beijing, China for a workshop – Preparing and Submitting Dossiers for Generic Drug Approval.Please Click here for more information on the Pharmaceutical Regulatory Summit Asia.


Kenny Peng Speaks at the Hong Kong Pharmacy Conference

March 15-16, 2014

Kenny Peng, Director from PharmEng Technology, will be speaking at the Hong Kong Pharmacy Conference 2014.

Date: March 16, 2014

Time: 11:00am – 11:40am

Topic: Design of a PICS/S GMP Biological Facility – an experience from Taiwan

Please click here for the agenda.


PharmEng Technology Sends Consultants to Shanghai, China to Assist a Major Pharmaceutical Company

February 28, 2014


PharmEng has been engaged as Director of Commissioning, Qualification, and Validation for a new aseptic biopharmaceutical facility in Hebei, China. The project, backed by the Client's US parent company, is conducted in collaboration with a local CQV team in Shanghai, China.

PharmEng Technology Exhibits INTERPHEX 2014 in New York City – March 18-20, 2014 BOOTH #2457

 February 24, 2014

Please visit us at INTERPHEX 2014 which will be held at the Javits Center in New York City March 18-20, 2014. Click here to register as our guest and receive FREE exhibit hall admission.

Please stop by our Booth #2457to learn more about our services or to speak with our Business Development team to discuss your needs. If you are in New York for the show and would like to book a meeting with our Business Development team please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

For more information on INTERPHEX click here.

PharmEng Technology Provides QA Support to a Major Medical Marijuana Facility

February 21, 2014

PharmEng Technology has been engaged by a large Medical Marijuana Manufacturer to develop all their quality systems. We will be working with them to ensure that they are in compliance with federal regulators in order to obtain their site licence.


PharmEng Technology starts the new year of 2014 with a big bang!

February 3, 2014

PharmEng begins 2014 with a big bang as we have been engaged by a multi-national pharmaceutical company for a significant decommissioning project.


PharmEng Technology contributes to ISPE magazine Pharmaceutical Engineering (July/August 2013)

Congratulations to Kenny Peng, Director of Aisa for PharmEng Technology, on the publication of his article, “Good Manufacturing Practices for Halal Pharmaceuticals,” in the July/August issue of Pharmaceutical Engineering magazine!


PharmEng Technology is now certified to ISO9001:2008!!!

June 10, 2013

ISO 9001 is an international quality standard developed by the International Organization for Standardization (ISO), a worldwide federation of national standards bodies representing some 130 countries. It provides a structured yet flexible framework for a customer focused business management system that will drive business performance improvement.

PharmEng Technology is certified with NMSDC (National Minority Supplier Development Council)

April 16, 2013

NMSDC’s rigorous certification process is considered the gold standard for certifying minority-owned businesses by corporate America. The NMSDC Affiliate Regional Councils located throughout the country are responsible for certifying businesses owned by Asian, Black, Hispanic and Native American business owners using guidelines established by the National Minority Supplier Development Council.


PharmEng Technology is certified with CAMSC (Canadian Aboriginal and Minority Supplier Council)

April 16, 2013

CAMSC corporate members are investing in an inclusive supply chain for a variety of reasons, such as the opportunity to access newer innovative suppliers, as well as the opportunity to create wealth, employment, and build brand loyalty with aboriginal and minority communities.


PharmEng Technology contributes to RAPS online magazine

April 10, 2013

The RAPS Feature article on Singapore GDPMDS compared to ISO 13485 is shown up on the Regulatory Affairs Professionals Society website for May edition. It is co-authored by Kenny Peng, Director of Asia for PharmEng Technology.

You can read it up here. 


PharmEng Technology Speaking at ISPE China Annual Meeting

April 3, 2013

Kenny Peng from PharmEng Technology will be featured as a speaker at the ISPE China Annual Meeting 2013. On April 22 at 8:05am-8:30am (Track A), Mr. Peng will be presenting Good Distribution Practices - A Case Study on an International Technology Transfer.

Please click here for more information about ISPE China Annual Meeting.


PharmEng Technology Training Program

March 3, 2013

PharmEng Technology will be at the National University of Singapore presenting a training program on Computerized System Validation. The program takes place on March 14-15, 2013 from 9am-5pm. Please follow this link for more information.

PharmEng Technology will be at the National University of Singapore presenting a training program on Fundamentals of Regulatory Affairs. The program takes place on March 20-21, 2013 from 9am-5pm. Please follow this link for more information.

More courses under NUSAGE-PHARMENG Pharmaceutical and Technology Training Program are coming:

   22-23 Aug. 2013    Analytical Method Validation

   18-19 Sept. 2013   Equipment Qualification for Pharmaceutical Facility

   24-25 Oct. 2013     Effective Quality Assurance-Audits, Annual Review, Events Handling and CAPA

   14-15 Nov. 2013    Distribution, Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices Internationally

   10-11 Dec. 2013    Stability Studies for Pharmaceutical Products (API and Finished Products)


FDA Draft Guidance Aims to Clarify Difference Between Recalls and Removals

February 22, 2013


Reducing Validation Time and Cost: How GAMP & Risk Based Approaches are Reducing Cost

February 18, 2013


The Concept of Air Handling System Validation

January 29, 2013