Effective cleaning and disinfection of controlled unsanitary areas are fundamental in achieving and maintaining pathogen control in isolated, sterile, and contaminated regions. However, these practices were not always well understood, accepted, or adequately documented.
While this article focuses on cleaning and disinfection documentation details, the reader is encouraged to review the information presented in sanitizing engineering controls requirements and best practices (pp&p, september 2013), which provides a detailed analysis of the following information. Scope of this article:
General cleaning principles
- Special activities should occur more frequently than daily and monthly
- Information on cleaning hazardous drug sites
- Written policies and procedures, staff training, and competency certification
Impact of usp
Documentation of cleaning and disinfection in contaminated areas must be consistent and provide sufficient detail to ensure that activities are performed as described in policies and procedures. It is because of the agency (p&ps), but not so much as to be overwhelming. This begs the question of how small?
How much is too much? And, what exactly is needed? To address these questions, presented here are suggestions for best practices that also incorporate the requirements of the usp chapter.
1 however, it must be noted that chapter does not represent best practices. ; instead, it describes the minimum standards for practice.
It is also important to mention that many state boards of pharmacy use the chapter to promulgate their unsanitary compounding regulations. Some countries can adopt usp chapters by reference and therefore require precisely what they say, although differences somewhat influence how the government defines the standards.
On the other hand, some countries cannot adopt usp chapters by reference and instead cut and paste chapter requirements into their jurisdiction and add their country-specific changes as they go along. Therefore, every compounding for pharma clean room must understand and follows its state drug regulations.
Characteristics of suitable document formats
Documentation is achieved using paper forms or web-based quality management systems. The current system of health care documentation relies on electronic devices, which have the advantage of providing accurate data and sending alerts when things are not completed or recorded.
These systems can also offer performance and results-based reporting and discipline. Any method is adopted as long as the data is received in a timely and accurate manner. Whether electronic or paper, well-designed forms should reflect the following characteristics:
- Be 100% compliant with written p&ps.
- Provide tangible information to employees, preferably in multiple ways
- Find specific information and details required by the regulations
- Be easy to use
Allow methods for significant results
Documentation is best done by those who complete the cleaning tasks immediately after the solution preparation or cleaning, and disinfection tasks are completed. To ensure that documentation is complete, accurate, and up-to-date, paper forms and logs should be routinely but informally reviewed by those in charge of biological integration.
In addition, the clean pharmacy manager (or designee) must sign off on each form; depending on the nature of the state; signing can be done weekly or monthly.
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If the manager, during the inspection of the cleaning documents, notices the conditions of incomplete or incorrect documents, follow-up actions with those employees should be recorded. It can be done as quickly as writing follow-up actions in a log form.
Create document retention policies
Every pharmacy should have a record-keeping policy, as many federal and state agencies have guidelines that define what hospitals, community pharmacies, and other health care providers can do.
How long must we keep certain documents?
However, compliance with minimum record-keeping requirements may often not be sufficient to protect an organization when contractual, regulatory, or legal issues arise beyond the usual two to three required by most countries—pharmacy boards.
For example, hospitals are required by state law to keep records such as batch logs and other specific patient information for less than seven years.
In addition, many states require hospitals to keep medical records for seven years from an adult patient’s discharge date. Pediatric patient records must be kept for seven years from the date the patient is discharged or until the patient reaches the age of majority, whichever is longer.
Paper-based cleaning documents are usually kept in a ringed binder in a large pharmacy, where they are easily accessible to staff, managers, and auditors. However, no matter where the information is stored, it must be easy for those who need to write their work. It must also be readily accessible to authorized persons who wish to inspect it.
Examples of authorized persons who may and may request this information include representatives of:
- State boards of iso5 cleanroom
- Accreditation organizations
- Food and drug administration
- National departments of health
- Centres for medicare and medicaid services
Organizational quality/employee compliance
Each person can review the cleaning documents for details, quality, and completeness. They will also review written procedures to determine if they reflect current laws and best practices and compare records and systems to determine compliance with the policy.
Some auditors may ask to access your electronic quality control documents, so be prepared to set up access with view-only permission and help them run the system. They can also request the publication of information for their audit reports.