We develop and write in cooperation with you all SOPs and check your work instructions periodically and regularly in order they are always at the newest stand. Your SOPs are adapted according to the changed conditions.

The time intervals which defines the periodically review of your SOPs are fixed by you. Though, we counsel to not wait more than two to three years until you check your SOPs.

Work instructions shall be bases of action and decision norms and help supervisors as well as employees to act and to decide technically correctly.

The term of "work instruction" is covered with a variety of synonymous:

• Method description (EC-GMP manual),
• Written Procedure (21 CFR 211),
• Standard Operating Procedure (SOP),
• Standard method instruction,
• Method instruction,
• Production instruction,
• Test instruction,
• Test specification,
• Operating instruction etc.

The aim of work instructions is that quality relevant work and processes are executed by

• everybody
• straight off and
• correctly!

It also is made clear with that that the addressees of work instructions are primarily the employees of the enterprise. Work instructions serve of course only in a secondarily way for external (e.g. customers, authority representatives).