Services – GMP

Intellitech covers the spectrum to support customers from R&D to GMP.

Document

Intellitech creates, approves, releases and maintains the required documentation to support GMP requirements

As a qualified supplier to top pharmaceutical manufacturers; Intellitech creates, approves, releases and maintains the required documentation to support GMP requirements; including Drawings, Bill of materials, Work Instructions, Data Collection Forms, Batch Records, Certificate of Conformance. The company’s document control system employs a validated electronic workflow process that meets the requirements of 21CFR820.

Qualify

As a critical element of GMP, Intellitech identifies and qualifies suppliers of component parts.

In addition, supplier performance is continually monitored to meet requirements for on time delivery and rejected material.

Validate

Intellitech supports customers to validate processes and define acceptable operating ranges, critical quality attributes, and acceptance criteria of the intended system(s).

The company partners with accredited labs for testing seal strength, integrity, bio burden, sterility, and shelf life. Intellitech coordinates with customers to capture the evidence required to assure production control.

Control

quality issues are identified and resolved prior to shipment to the customer

Intellitech’s highly performing Quality Management System controls production monitoring, Lot # traceability, Sampling, NonConformance, Deviation, Change control, Corrective Action, Audit, Trend Analysis, and system improvement to insure any quality issues are identified and resolved prior to shipment to the customer. If, however, a customer identifies a nonconforming product, Intellitech has processes in place for customer feedback, returns and corrective action to resolve issues.