12 FREQUENTLY ASKED QUESTIONS on SOPs

Answer: SOPs should be reviewed at least every two years. If an SOP is revised in between the two-year window, it should be reviewed thoroughly at the time of a revision. If the proposed revision affects related SOPs, they should also be reviewed for impact before the SOP revision is made affective.

Question: How many SOPs should I have in my system?

Answer: There is no set rule or formula regarding the number of SOPs needed for a functioning system. The number of SOPs needed depends on the activities the company is performing. We recommend writing SOPs that reflect your operations and avoid having SOPs in your system for operations you do not perform.

Question: What format do you recommend for SOPs?

Answer: There is no one correct format for SOPs. The format you chose will depend on the operation you are defining and the  experience and makeup of your workforce. Acceptable formats for SOPs include using play script, general paragraph form, flow charts, pictorial or any combination to communicate the SOP operation to the workforce. Whatever style you decide to use be sure that your SOP format includes the following recommended elements:

Unique identifying number and title
Effective date
Purpose and scope
Roles and responsibilities
Change history
Official signatures
Step-by-step instructions

Question: What do I do when I obsolete an SOP?

Answer: You should only obsolete an SOP if your company is no longer performing the activity described by the SOP. The SOP should be obsoleted using the change control system. It is critical that you review SOPs related to the one you are obsoleting and determine if they need revision as a result of the obsoleted SOP. In addition, any forms associated with the obsoleted SOP should be collected and destroyed. The obsoleted SOP and associated forms should remain on file in case they need to be referred to but they should clearly be stamped as being obsoleted.

Question: How much time should I allow for training on SOPs?

Answer: There is no set time regarding the amount of time allowed for training on SOPs. The amount of time needed to train on an SOP depends on your operation. Companies with multiple sites affected by the SOP may need additional time to train than a smaller company with just one site. We recommend, as a general rule, that you allow two weeks to train on an SOP.

Question: What is the difference between a release date and an effective or official date?

Answer: The release date for an SOP indicates that the necessary revisions have been approved and the SOP is ready and available for training. Once the training is complete and documented, the SOP can be made official and used by the employees performing the described operation. We recommend, as a general rule, that you allow two weeks to train on an SOP before you make it official.

Question: Should a company use the same date format whatever it decides or can a variety of formats be used provided the date is clear and legible?

Answer: Dictating one date format versus another can create unnecessary and irrelevant deviations. The requirements for the date are that it should be legible and readable. Acceptable date formats include:

mm-dd-yy, where the month, day and year are numerical separated by hyphens.
mm/dd/yy, where the month, day and year are numerical separated by slashes.
30 Aug15 or 30 Aug 2015, where the day and year are numeric and the month is alphabetic.

Whether you decide to specify a date format or not, remember that the critical elements for a date if legibility and readability.

Question: When pictorials are used, is it recommended to reference the SOP number?

Answer: Yes. This will make it much easier to track the documents for necessary revisions.

Question: Are electronic signatures acceptable on SOPs?

Answer: Yes, electronic signatures are acceptable on SOPs. We recommend that if you have electronic signature capabilities be sure you comply to 21 CFR 11 and can provide an audit trail upon request. In addition, we recommend that individuals who have the authority to approve SOPs electronically have a unique account and password to avoid any data integrity issues.

Question: Can you have two different expiry dates? For example, SOPs for instruments reviewed every four years and SOPs regarding quality systems (OOS, OOT, change control, audits) every two years.

Answer: Yes, you can have two different review periods for various SOPs in the system. You should document your rationale for why you have chosen these time frames for review. However, whether you review your SOPs on a two-year or four-year cycle, SOPs revised in between the defined cycle should be reviewed thoroughly at the time of a revision. If the proposed revision affects related SOPs, they should also be reviewed for impact before the SOP revision is made affective, regardless of what cycle period they are on.

Question: If an SOP gives step-by-step instructions then what is a “workinstruction” and when would it be necessary?

Answer: There really is no need for work instructions if you write your SOPs in a clear and concise manner.

Question: Is there an expectation that the change history be contained within the SOP?

Answer: Common industry practice is to include the change history of the SOP within the document but there is no requirement that you must include it in the document. If you chose not to include the change history in the document be sure you capture it in a controlled system that is available for answering questions during an inspection or audit.

SOPs Clear and Simple: For Healthcare Manufacturers

By Brian Matye, Jeanne Moldenhauer, Susan Schniepp

Available as book and pdf Single user.

www.pda.org/bookstore/product-detail/4787-sops-clear-and-simple