Standard Operating Procedures

MCS Associates will develop, write, implement and maintain a system of Standard Operating Procedures for your firm to insure that your operational tasks are well documented and in accordance with current regulations that are relevant to your product line.

SOPs are usually comprised of a set of instructions and attached documents that provide evidence (logs or forms) that the procedures were actually followed. The concept underlying the requirement for an SOP is to insure that a particular operation is conducted in the same way every time to insure a particular standard.

Adherence to SOPs makes them VALID!

There is absolutely no point in committing to certain policies and practices if these policies are not relevant to your company operations.

SOPs are typically written in the context of a particular standard or set of regulations. The standard depends on the industry. In the pharmaceutical or natural health product industry the standards of practice are embodied in the Good Manufacturing Practices.

Writing SOPs is a skill set that requires expertise in regulations and business operations.

SOPs must be written in a way that accurately reflect the practices of the company but still maintain the spirit of the regulations.

For example, as a regulated product manufacturer you must insure air quality, however, the rigidity of the standard depends on the class of product that your company is producing. The same may be true with validation requirements

"Training, training, training………"

SOP training is a vital part of any good training program as it alerts relevant personnel to the specific policies related to their job function. The GMP acronym is a little misleading in the sense that the GMP also extend to activities that are not necessarily manufacturing but are still related to handling of the product (importation and distribution).

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Quality Assurance
MCS consultants write Standard Operating Procedures for your company.
Quality Control
MCS consults on behalf of companies on the administration of Standard Operating Procedures.

MCS is able to train your employees once the Standard Operating Procedures have been designed.
MCS Associates Inc. play key roles in both of these critical Quality functions.
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