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Asia Pacific

Singapore

Singapore

#03-20 Galaxis

1 Fusionopolis Place

Singapore, 138522

P: +65 68365524

Malaysia

Kuala Lumpur

Jland Biz Centre – Menara JCorp

No 249 Jalan Tun Razak

Kuala Lumpur, Malaysia 50400

P: +60 3 27872666

Indonesia

Jakarta

Ruko Citra Garden 6

Tegal Alur, Kalideres, Jakarta Barat

DKI Jakarta, Indonesia

P: +62 21 2789 9789

Taiwan

Taipei

11F-5, No. 91,

Hua Yin Street Taipei,

Taiwan 103

P:+886-2-55746135

Hong Kong

Hong Kong

8/F. Park Sun Building

No. 97-107 Wo Yi Hop Road

Kwai Chung, Hong Kong

P: +852 5801 0188

China

Hanghzou

866 Yuhangtang Road

Xihu District

Hangzhou, Zhejiang

P.R. China 310058

P: +8618989496483

Vietnam

Hanoi City

116c 2F Quang Trung Street

Tran Hung Dao Ward, Hoan Kiem

Hanoi City, Vietnam

Myanmar

Yangon

No. 520, Kabar Aye Pagoda Road

Rm. 206, Excel Tower

Bahan Township, Yangon

Myanmar

P:+65 68365524

North America

Canada

Toronto, ON

23 Lesmill Rd., Suite 410

Toronto, Ont. M3B 3P6

P: 416-385-3922

USA

Cary, NC

2500 Regency Parkway

Cary, NC 27518

P: 1-855-937-2497

USA

Atlanta, GA

200-2475 Northwinds Parkway

Alpharetta, GA 30009

P: 1-855-937-2497

Europe

Ireland

Cork, Ireland

The Cube Building,
Monahan Road,
Cork, Ireland.
T12 H1XY
P:+353 21 2376009

Spain

Barcelona, Spain

Av. Diagonal 409 1st floor

08008, Barcelona, Spain

P: (+34) 673 565 099

Latin America

Brazil

Pina, Recife

Av. Eng. Antonio de Goes, 60 Sala 702

Edf JCPM Trade Center 51.010-000

Tel: +55 81 4042 9049

Validation

Our team of experts will prepare necessary protocols incorporating all critical parameters
See All Services > Validation

Process Validation

PharmEng professionals possess experience in validating pharmaceutical and biopharmaceutical manufacturing processes. Our team of experts will prepare necessary protocols incorporating all critical parameters of the process. Execution will incorporate data analysis and resolve any non-conformances. PharmEng will collect and evaluate data to ensure that a process is capable of consistently operating according to determined standards. Our professionals provide effective process validation which contributes significantly to assuring drug quality.

Our project execution will include evaluating the process capability of the manufacturing and testing procedures using statistical techniques. By teaming up with the R&D, Operations, Quality Assurance, Regulatory Affairs personnel, PharmEng will ensure that all regulatory requirements and specifications are met.

Our project management skills will ensure that all documentation, written and provided, will meet the standards of international regulators and the Quality Assurance team. Our team’s results and deliverables are well accepted by FDA and Health Canada regulatory bodies. PharmEng will provide your company with results that exceed your expectations.

Validation
Validation

Cleaning Validation

PharmEng possesses a group of highly experienced professionals for cleaning validation procedures that are recognized and exceeds the expectations of FDA and Health Canada regulatory bodies. Our consultants will utilize their skills and knowledge to ensure all parameters including worst case scenarios are tested for and validated. We understand the importance of complying with regulatory guidelines for the cleaning of all critical equipment.

We can develop and execute cleaning protocols by challenging the current cleaning procedures in extreme case conditions to ensure the protocol will be effective during any given manufacturing situation. In addition, we will determine the most effective analytical methods and rationalize the appropriate limits for the acceptance criteria.

PharmEng has a proven track record of excellence by developing Cleaning Validation master plans, cleaning validation protocols, and swab recovery studies. We strive to personalize our services to cater to your company standards by working closely with your validation, engineering, quality assurance and regulatory affairs department.

Computer Validation

Computer systems have become an integral part of the manufacturing process for regulated products. Regulatory agencies have taken the approach that the verification of computerized processes requires additional testing, and they have developed specific criteria for validating computer systems.

The validation of computer systems not only ensures compliance to these regulatory standards, but also enhances the integrity of your automated processes and your electronic data. Whether you are implementing a complex LIMS application or would like to validate an Excel spreadsheet, PharmEng has the expertise to ensure compliance of your computerized systems.

Validation