Pharmaceutical QMS Templates

Built in Microsoft® Word for easy editing, these templates are the quick and easy way to build a Quality Management System (QMS) for ISO, GMP or other regulatory compliance.

The templates are used by our consultants in the field and are full of practical guidance and how-to instructions. They are easy to use and will save you weeks, if not months, of time.

Ideal for startup pharmaceutical or life science companies who must comply with TGA or FDA GMP guidelines.

The content of the templates supports the requirements of the:

• PIC/S Code of Good Manufacturing Practice, and/or
• ICH Pharmaceutical Quality System Q10, and/or
• ISO 9001:2008 Quality Management Systems (for Pharmaceuticals)

Price is: A$1000 + GST. Purchase and download from our pharmout.com.au website.

What's included in the QMS template pack?

Pack includes templates for developing Policies, Standard Operating Procedures (SOPs) and Work Instructions for the following areas of your business:

• product information, quotations and orders
• product development
• production and quality planning
• purchasing and receiving
• production
• labelling, packaging, shipping and distribution
• monitoring and measurement of products
• monitoring and measurement of the Quality Management System
• monitoring customer feedback and satisfaction management policies, planning and commitments
• management review
• human resources
• plant, facility and equipment
• information resources
• measuring and monitoring devices
• continual improvement

These areas are specified as being essential components of a pharmaceutical quality management system by the various regulatory bodies e.g. TGA, FDA.

Get a head start with nearly 40 pre-written standard operating procedures

The ideal resource for a quick and easy do-it-yourself QMS implementation, the template pack includes 38 procedure templates, 19 form templates and several guidance documents.

Get help from our regulatory compliance experts

Included in the price is two hours of support via telephone or email. Feel confident in the knowledge that if you have questions or get stuck then you can speak to a GMP compliance specialist to set you on the right path.

Our consultants have many years of experience working in the pharma and medical device industries. You can benefit from their knowledge of what works and what doesn't when creating and maintaining a pharmaceutical quality management system.

Free Change Control Standard Operating Procedure

Download a free SOP covering change control for pharmaceutical manufacturing. It's included in the template pack but you can download and try it out for free now.