The meaning of SOPs for your company

A standard operating procedure, or SOP, is a written set of step-by-step instructions on how an employee should handle a specific task or situation that arises in business. The purpose of a standard operating procedure is to ensure the successful outcome of a task and to make sure the outcome is consistent no matter who completes the task.

An important aspect of a quality system is to work according to unambiguous Standard Operating Procedures (SOPs). In fact the whole process from sampling to the filing of the analytical result should be described by a continuous series of SOPs. A SOP can be defined as follows: "A Standard Operating Procedure is a document which describes the regularly recurring operations relevant to the quality of the investigation. The purpose of a SOP is to carry out the operations correctly and always in the same manner. A SOP should be available at the place where the work is done".

  A SOP is a compulsory instruction. If deviations from this instruction are allowed, the conditions for these should be documented including who can give permission for this and what exactly the complete procedure will be. The original should rest at a secure place while working copies should be authenticated with stamps and/or signatures of authorized persons. Several categories and types of SOPs can be distinguished. The name "SOP" may not always be appropriate, e.g., the description of situations or other matters may better designated protocols, instructions or simply registration forms. Also worksheets belonging to an analytical procedure have to be standardized (to avoid jotting down readings and calculations on odd pieces of paper). A number of important SOP types are:

- Fundamental SOPs. These give instructions how to make SOPs of the other categories.
- Methodic SOPs. These describe a complete testing system or method of investigation.
- SOPs for safety precautions.
- Standard procedures for operating instruments, apparatus and other equipment.
- SOPs for analytical methods.
- SOPs for the preparation of reagents.
- SOPs for receiving and registration of samples.
- SOPs for Quality Assurance.
- SOPs for archiving and how to deal with complaints.

 

Pharmaceutical > Quality Systems

• Quality Systems audits/assessments, pre-certification audits, Quality Systems implementations, process improvement, SOP development, work instruction and procedures development
• ISO certification assistance
• Corrective and Preventative Actions (CAPA) processes and systems services
• Device master record/technical files remediation

PHARMACEUTICAL PRODUCTS

Pharmaceutical manufacturers are faced with a continually tightening regulatory landscape. In fact, the EMEA initiatives focused on increased vigilance of pharma companies from supply chain through post-market surveillance. It is imperative that a proactive approach is taken to construct the robust quality and compliance infrastructure that the EMEA demands.

MeekSystems Corp. has been providing professional services to pharmaceutical companies since 2008. We have deep regulatory, quality, and technical experience that reaches across virtually all functional and technical areas including sales and marketing, manufacturing (whole & partial ), importation from third countries, laboratory, clinical, pharmacovigilance and supply chain (wholesale, retail, distribution ) management.

Our approach to every project creates a unique synergy between compliance objectives and results-oriented business goals.

The consequences of a reactive quality and compliance program have been promised by the EMEA to be far greater than the costs associated with building a solid quality and compliance infrastructure proactively. If this opportunity cost is too high for your organization, contact MEEKSYSTEMS CORP. right away to proactively face the EMEA's quality and compliance expectations with confidence.