GMP Documentation Clause Samples
GMP Documentation. 4.1 Objective To prepare GMP documentation for use in manufacture of Product for Phase II/III clinical trials.
GMP Documentation. Neither party shall make any changes to GMP documentation without the consent of the other party, in order to insure that all GMP documentation, which is maintained at DSM and subject to regulatory review, matches or is consistent with information filed with regulatory authorities.
GMP Documentation. In order to ensure compliance with current GMP, and any other applicable regulatory requirements or guidelines, compliant documentation from batch records, analytical methods, final release testing, etc. will be generated specifically for the HPV RNA Transcript and HPV DNA Products. GMP documentation, including batch records, will be available for GPRO review.
GMP Documentation. OBJECTIVES: The objectives of the Project initiation are as follows: