How to Write an SOP for Cleaning in the Pharmaceutical Industry

Standard operating procedures for cleaning equipment are crucial in the pharmaceutical industry.

In the development of any pharmaceutical product, poorly written or non-existent standard operating procedures, or SOP's, can be enough for governmental agencies to reject the product from further development, whether it's the next stage in clinical trials or approval to the commercial market. Cleaning equipment properly and to consistent standards is crucial in the pharmaceutical industry, and SOP's must be adequate so that those standards are met.

Instructions

Title Page and Page Setup

1. Create a title page for the SOP formatted with a header and footer. The header should contain the title of the SOP. Be descriptive in the title (e.g. "Cleaning the Jet Pulveriser Mill" would be a more descriptive title than "Jet Pulveriser Mill"). Add the SOP's identification number, along with its revision number ("fifth revision") and implementation date.

2. Include in the footer the SOP number, revision number, and the name of each of the departments that will be affected by the SOP. Also include the department that initiated the SOP.

3. Insert the page number in the right hand corner of the footer; a common format for SOP pagination is one of the total number of pages (for example, "Page 5 of 13").

4. List below the header the people required to review and sign off verification of the procedure (use job titles rather than employee names, so the SOP will be useful even if there are personnel changes). Include sufficient spaces beside each position for the person's printed name and signature. The list should be composed of the initiator of the SOP, reviewer(s); someone who understands the procedure and can verify the procedure works, and from the head of the quality assurance department. Depending on the procedure, more than one reviewer may be required.

Objectives

1. Describe the objectives of the SOP. Expand on the title if necessary to differentiate one procedure from another (for example, "Cleaning a Jet Pulveriser Mill" as opposed to "Inspecting a Jet Pulverizer Mill").

2. Identify any other departments that may be involved in carrying out the procedure. For example, the maintenance department will likely be needed to dismantle the equipment, or a quality-control employee who must inspect the procedure.

3. Identify extraordinary safety measures or company protocols that may be required in the procedure. For example, note if the process requires workers to enter a confined space, or if the process involves risky operations such as welding or sending workers into an oxygen-deficient space). Each safety measure should have its own SOP; reference those and any other SOP's that are associated with performing the procedure.

4. Identify all of the allowable cleaners, solvents and detergents that can be used to perform the cleaning.

Procedure

1. Identify by job title who is responsible for performing the task and who is responsible for implementing the task. For example, a technician is usually responsible for performing the task as per this SOP and a supervisor is responsible for ensuring the technician is trained and performs the task.

2. Describe all of the necessary safety equipment required to perform the procedure, such as personal protective equipment and grounding equipment to deter static electricity discharges.

3. Describe how all tools and equipment should be cleaned and inspected prior to use.

4. In step-by-step, chronological order, describe how the procedure must be carried out. Include any testing or sampling that may be required between steps. Be sure to number each step.

Review and Approval

1. Include a section for review, comments, dating and signatures from the head of the environment, health and safety department. Any concerns identified with the procedure from that department must be addressed before the SOP can be signed, dated, and implemented.

2. Include a section for review, comments, date and signature from the head of each department identified in the footer of the title page. Any concerns identified with the procedure from any of those reviewers must be addressed before they sign and date the SOP.

3. Include a section for review, comments, date, approval and signature from the head of the quality-assurance department. Once all concerns with the procedure from any of the reviewers are addressed, quality assurance can sign and date the SOP as approved. The department will then assign the appropriate SOP and revision number to the procedure as per the company policy.

4. Add a "training record," which will be a list of which employees completed the training and when.

Implementation

1. Train and record on the training record the name of each person trained and the date of the training. At least one person other than the initiator must be trained before the procedure is implemented.

2. Sign and date the title page and have the appropriate reviewers sign and date the title page.

3. Return the SOP with the completed training record to the quality assurance department. Quality assurance will sign and date the title page, then implement the procedure into circulation.

Tips & Warnings

• Checklists for recording the dates and initials of those performing a task can be useful. Any checklists would be generated as exhibits attached to the SOP and not part of the body of the SOP, although they should be referenced at the appropriate steps in the SOP.

• A training record is essentially a file that when requested, can be shown to clients or governing bodies during audits as proof of training.

• Ensure all necessary personal protective equipment is worn as required.

• Consult the appropriate MSDS (material safety data sheet) for each of the solvents or chemicals to be used.

• If any flammable solvents or chemicals are to be used, ensure proper grounding procedures are applied.

References

• Pharmainfo: "Standard operating procedures (SOP) - Back Bone of Pharmaceutical Industries"