GUIDELINES ON THE PREPARATION, MAINTENANCE AND CONTROL OF DOCUMENTATION

PRODUCED BY

A WORKING GROUP OF THE SCOTTISH QUALITY ASSURANCE SPECIALIST INTEREST GROUP

SECOND EDITION

DECEMBER 2004

Contents
Page Number 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Introduction Types of documents Preparation of documents Document control Maintenance of documents Storage and archiving Electronic documents Labels Change control Bibliography 2 3 4 7 8 9 10 11 12 13

Appendix I - Example of a Change Control Form

1.

Introduction

The purpose of this document is to give guidance to staff in Pharmacy departments on the writing and maintenance of the different types of documents, which may apply in Pharmacy practice. All staff in Pharmacy Departments should appreciate the need for comprehensive documentation systems. 'Rules and Guidance for Pharmaceutical Manufacturers and Distributors' (Orange Guide, 2002) states that 'Good documentation constitutes an essential part of the Quality Assurance system' Clearly written comprehensive documents prevent errors that may arise from spoken communication, and permit traceability of all activities. Any document, whatever its purpose, should be as detailed as possible, unambiguous, and written in language which is commensurate with the level of understanding of the intended user. Each department should have a written approved procedure stating who can write and approve documents, and giving details on the control, review and archiving of documentation.

2.

Types of Documents

A complete documentation system will comprise: Quality Policy - a short statement outlining the organisation's commitment to quality (i.e. a 'mission statement'). This will usually be prepared at a high level within the organisation and circulated to departments, although some departments may have their own policy statement. Quality Manual - a detailed document that sets out protocols and policies relevant to the department. (For a licensed site, this may be incorporated into the Site Master File, which is submitted to the licensing authority). Procedures - Standard Operating Procedures (SOPs) provide detailed instructions on how to perform specific tasks. For an aseptic dispensing unit, they will include instructions on cleaning, transferring products and monitoring, as well as details of how to carry out aseptic manipulations. For the clinical pharmacy service, they will include instructions on completion of care plans, patient counselling etc. Records - these are perhaps the most important documents of all, since they provide a permanent written history of every aspect of the process undertaken. Reference Documents - every department will use other reference documents on a day-to-day basis. These may be textbooks (e.g. the BNF) or other procedural documents required by the organisation.

3.

Preparation of Documents

The main types of document that are likely to be written by Pharmacy staff are Standard Operating Procedures (SOPs) and records. Each should be fit for its intended purpose. All documents should include: The name and address of the department/section to which it refers; A title; Date of Issue; An unique reference number (e.g. ABC123-2); A reference to any previous documents referring to the same topic/procedure (e.g. Supersedes ABC123-1); A version number or revision status; The signatures of the persons writing and approving the documents, along with their respective titles; A date after which the document must be reviewed; The document should state at the outset for whom, and for what purpose, it is written. Each page should be numbered and should show the total number of pages in the document (e.g. Page 1 of 4 pages of ABC123-2). Each page should be marked so that the document and version number is clearly and uniquely identified. Documents should be written by a person who is familiar with the processes referred to in the text, for example by the production pharmacist (or technician manager), dispensary manager, office manager or storekeeper. In some circumstances a second check may be performed, for example a document may be written and checked by two separate technicians before being submitted for approval. In this case all relevant signatures should appear on the document. If the document is printed (word-processed) by clerical staff, it should be returned for proofreading to the writer. Documents should be approved by an independent authorised person who is sufficiently familiar with the processes referred to in the text, for example the Quality Assurance Pharmacist or the Operational Services Manager. All documents should be written using language commensurate with the level of understanding of the intended user. When a new document is introduced, there should be a system in place to ensure that relevant staff are aware of its introduction. There should be a record showing that staff have read, and that they understand, the document.

Standard Formats Staff who intend to write documents should check if there is a standard format in use within the organisation. A sample template of the format that should be used for preparation of documents may be available. 3.1 Standard Operating Procedures

Documents that give detailed instructions on how to carry out a task or use a piece of equipment are known as STANDARD OPERATING PROCEDURES (SOPs) Instructions must be clear, precise and unambiguous; Each step should be numbered and written in the imperative and in a positive tone; The instructions should follow the intended flow of work in a logical manner; Safety precautions should be clearly detailed BEFORE the start of the instructions; Documents containing instructions should be validated prior to approval. (Validation may be effected by asking an independent person of the appropriate grade to carry out the procedure strictly according to the written instructions: if the instructions are satisfactory, the person should be able to complete the task without assistance). Records

3.2

Examples of activities for which records may be required are: Worksheets for manufacturing and packing; Worksheets for extemporaneous preparation; Worksheets for aseptic dispensing Logs of equipment use (e.g. balances); Equipment function checks; Routine environmental monitoring; Medicines Information enquiries; Care plans; Records of interventions; Receipt of goods; Consignment notes; Picking tickets.

Records differ from instructions in that staff are required to input information: therefore the document should be written in such a way as to facilitate appropriate and correct recording. Sufficient space should be available for writing details. The document should discourage the use of tick-boxes and encourage the entering of actual data, e.g. mixing times, temperature readings, initials, where this is appropriate. In some cases tick-boxes may be used for the collection of statistical information. All entries should be made in black or blue ink. Corrections should be made by scoring (once only) through the original text and writing the corrected text next to it. Corrections should be initialled and dated. Corrective tape or ink, which obliterates the original text, must not be used 5

3.2.1

Copying Worksheets

Worksheets are records which provide instructions for carrying out specific processes combined with space for details of individual operators, batch numbers etc. to be inserted. Worksheets are often photocopied in quantity for ease of future use. There should be a system in place for ensuring that all copies are checked for accuracy and clarity. There should be instructions as to the maximum number of copies that should be made at any one time.

4.

Document Control

In certain instances, it may be necessary to have more than one copy of each document. For example, in a large department copies of the Health and Safety Policy will be required for each section within the department. Each department should have a written approved policy on Document Control. This policy should be followed to ensure that only current copies of documents are in use, and that superseded documents are archived appropriately. The original (Master) copy of each document should be clearly identified and kept separately from any copies, for example in a Master File in the main Pharmacy or in the QA pharmacists file. Master copies may be identified by printing on (specified) coloured paper, or by plasticising/ laminating. Copies intended for routine use (working copies) may be made from the original. These should be identified as 'Controlled Copies'. Each working copy should be traceable to an individual section within the department. The document controller should be aware of the location of all controlled copies, and is responsible for ensuring that only the specified number of copies is in existence. A list of the locations of controlled copies should be kept in the Master File and maintained by the document controller. If further copies of a document are made, for example to distribute for reference to other departments, these should be clearly identified as Uncontrolled Copies. Once revisions are approved, they should be issued to the relevant sections. There should be a system in place to ensure that changes are communicated to the relevant staff. Document control should extend to documents used by the department but prepared elsewhere. This will include policies relevant to the department, national guideline documents, and textbooks used for reference (e.g. British Pharmacopoeia, Martindale). Reference books that are updated regularly (e.g. BNF) should be clearly identified as 'current issue' or 'superseded'. It is the responsibility of the Document Controller to issue updates of documents and to ensure that superseded versions are returned/destroyed. Any excess photocopies of superseded documents must be destroyed at the same time.

5.
5.1

Maintenance Of Documents
Reviewing Documents

All documents must be reviewed regularly at intervals of not more than two years or earlier if the person who wrote or approved the original document leaves the department. A person who is familiar with the processes referred to in the text should review each document. Reviewed documents must be submitted for approval. If it is considered that no changes are required, it may be sufficient to over-label the document to show the date of review, the initials of the reviewer and the next review date. 5.2 Revising Documents

All relevant documents should be revised as soon as possible after a change has been implemented in any system of work. Hand-written changes to documents should be discouraged. Minor changes (for example a change in the name of a detergent or disinfectant used) may be considered acceptable for a limited period. In this case the original text should be scored through (once only) and the alteration clearly marked in the margin. Corrective tape or ink, which obliterates the original text, must not be used. No more than three (3) hand-written changes should be permitted on any one page. Each change should be initialled and dated by the person making the change, and by the person who originally approved the document. Revised documents should be identified. Once revisions are approved, they should be issued to the relevant sections. There should be a system in place to ensure that changes are communicated to the relevant staff.

6.

Storage and Archiving

When revised documents have been approved, the original master copy should be removed from the Master File, clearly marked so that it is obvious that it must not be used, and archived (i.e. filed in a superseded documents file). The revised master should then be placed in the Master File. A record should be made in the Master File of the date on which each master is superseded. Archived master documents must be retained for at least three (3) years after the date they were last in use. They should be stored under appropriate conditions of temperature, light, humidity and absence of contamination so that they remain legible for the whole of this period. They should be stored so that they are accessible for reference if necessary. Documents, which contain information on particular activities, for example Batch Manufacturing or CIVAS preparation records, should be filed in such a way as to facilitate their retrieval if necessary. Some organisations may have individual policies on retention times for files and records: these should be followed. Standing Financial Instructions will contain information regarding retention times for invoices and delivery notes. It is becoming more common for commercial companies to be used for storage of records. If such a company is used, the efficiency of retrieval of a specified record should be challenged at regular intervals (e.g. annually). The outcome of such an exercise should be recorded.

7.

Electronic Documents

It is acceptable to store master documents on discs, CD-ROM, PC hard drives or network servers. At least one backup copy should be made and stored in a separate location. If backup copies are stored on network servers, this will be performed by the IT department and will meet standards relating to security. One paper copy of the document must be signed and dated by the writer and approver. The signed paper copy should be treated as a Master Copy and stored in the Master File for reference. Copies may be made from this master if required. Working copies, for example of packing records, may be made direct from discs and do not require to be signed: however reference must be made to the writer and approver on the document. There should be a system in place to control access (for example by high-level passwords) to documents stored on discs so that the contents cannot be altered. Only the version in current use should be kept on disc. All superseded versions should be deleted BUT the paper Master Copy must be archived. Security is particularly important where documents are computer generated. Access may be permitted for staff to change certain details such as batch number and expiry date, but access to make any other changes must be controlled by a higher-level password. 7.1 Validation of computerised documentation

Where computers are used to generate labels and worksheets, and/or where they are used to calculate dosages, there must be a robust system of validating the labelling and calculating process. This may be affected by performing manual calculations to check the dosages, or by routine meticulous checking of random samples from runs of labels. The results of such validation should be documented.

10

8.

Labels

It is common practice to generate labels using computer software. These may be simple wordprocessing programmes, or may involve fairly complex calculations. Where computers are used to produce labels containing individual patient dosage information, and where the calculation of the dose has been carried out using the computer software, it is essential that there is a system of routine validation and verification of the system. This should be carried out routinely, and should include challenging the system by inputting data at the outer limits of acceptance (e.g. a very high or low dose, a quantity of an additive at the upper level of solubility). Each TPN dosage regime should be checked regularly against a manual calculation. Copies of labels used for validation should be retained along with the name of the person carrying out the validation.

11

9.

Change Control

There should be a written approved policy for dealing with changes in documents and systems. This will ensure that all staff are aware of changes in procedures and policies An example of a change control form is attached (Appendix I)

12

10.

Bibliography

The following texts have been referred to in the preparation of this document: Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002 (Orange Guide) Aseptic Dispensing for NHS Patients (Farwell Report) 1995 Quality Assurance of Aseptic Preparation Services 3rd Edition Ed. A. Beaney

13

Appendix I: Example of a Change Control Form

Issue Number Title of Procedure Page Number Revision Number Description of Amendment Authorised by