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Further Guidance for UK Officially Recognised Efficacy Testing Facilities

Chemical Control Procedures

All chemicals should be uniquely identified (eg number/code), including unique identities for multiples of the same batch number.

The unique identification should be recorded on the booking in/booking out records, and on the chemical measuring records. This is to ensure that it is possible to tell which batch was used in a particular trial/test.

Chemical expiry date should be based on date of manufacture/expiry date, where known (the supplier could be consulted for advice on an appropriate expiry date where none is given on the bottle). Nominal expiry dates based on the date of receipt (eg two years from receipt) should only be used in the absence of this information.

Stocktaking procedures should be sufficient to ensure that where expired materials are held in the store they can be easily identified for removal/disposal and clearly marked as such, (eg with a permanent marker red cross).

The Standard Operating Procedure (SOP) should specify the options for the disposal of chemical stock, and the criteria for choosing a particular disposal route should be briefly explained (eg return to sponsor/disposal via a licensed contractor/overspray on farm). [It may be worthwhile to include any proformas used to facilitate these systems in an appendix to the SOP on chemical control].

EPPO Guidelines

According to Commission Regulation (EU) No 545/2011, the design and analysis of trials must be in accordance with European and Mediterranean Plant Protection Organization (EPPO) guideline 152, and trials must be carried out in accordance with specific EPPO guidelines, where available. Where details in the protocol, or SOP, are below the minimum specified in the relevant EPPO guideline, these should be justified in the protocol or the relevant SOP (this might be a simple justification, or may require reference to specific scientific evidence).

It is important that all deviations below EPPO are scientifically justified (it might also be worthwhile to include these justifications in the final trial report). Compliance with guidelines is one of the factors to be considered when reviewing SOPs and generating trials protocols. Note also that up to date copies of relevant EPPO guidelines should be available to all relevant staff.

EPPO guidelines can be purchased through their website at: http://pp1.eppo.int/

Sub-contracting

If phases of efficacy testing are to be sub-contracted to a non-"Officially Recognised" organisation there must be written guidance for this (in the form of an SOP). This guidance needs to describe systems that will ensure that any efficacy related work is carried out to the minimum requirements of Commission Regulation (EU) No 545/2011. Where work is carried out under supervision and to an existing SOP, it would be sufficient to have available a statement that the equipment used was properly maintained/calibrated, and that records are kept. Where unsupervised work is to be carried out by a contractor, the guidance must describe the information required to demonstrate that the work is carried out to a written procedure by suitably qualified staff, and using appropriately maintained and calibrated equipment.

Training records

Training records must be sufficient to demonstrate that individual members of staff are suitably trained and experienced to carry out their designated functions. They should consist of three main components; a CV, records of formal internal and external training (plus copies of relevant certificates) and a record of on-the-job training.

The CV should reflect appropriate general training and experience, while the records of formal and on-the job training should reflect competence in more specific areas (such as disease assessments, and familiarity with relevant administrative procedures, eg chemical booking). The record of on-the-job training could be SOP or task based, and should consist of:

For more experienced staff, competence in relevant tasks or SOPs could be based on "assumed prior competencies", and can be recorded as such.

Assessment Methodologies

Commission Regulation (EU) No 545/2011 requires that staff work to written operating procedures and protocols. It is therefore crucial that all assessment methodologies used in efficacy tests are fully described either in an SOP or in the trial protocol. The scope and detail of assessment methodologies must be sufficient to carry out the work, when used by suitably trained and experienced personnel.

In addition, Commission Regulation (EU) No 545/2011 states that crop phytotoxicity assessments are an essential component in all efficacy trials – including effectiveness and crop safety trials.

Protocol Content and Management

There must be a basic protocol for all efficacy trials/tests, in advance of the work being carried out. As a basic minimum, a trials/test protocol should contain:

Protocol amendments need to be recorded on or with the protocol (with a brief justification for the amendment) signed and dated.

Example:

Adding an extra treatment to the treatment list after it has been finalised and issued, but prior to work commencing (this may have been suggested by the marketing department of the organisation). This amendment can be recorded in one of two ways;

  1. By writing a comment directly onto the existing protocol, or
  2. By generating a new protocol with the additional treatment.

Either way, the procedure would need to be authorised (signed and dated) by an appropriate member of staff.

There must be a formalised procedure for issuing protocol amendments.

Protocol deviations need to be recorded in the raw data (again with a brief explanation for the deviation) signed and dated.

Example:

The disease target is present at levels that require treatment at growth stage BBCH 31 (earlier than the planned application timing). A decision is made to apply the treatments immediately, to enable the trial to remain within the criteria that it should be sprayed at the first signs of disease. This deviation must be recorded in the raw data, along with the explanation, signed and dated by the person who carried out the deviation.

There must be a formalised procedure for undertaking and recording protocol deviations.

Standard Operating Procedure (SOP) Content and Control

SOP Content

A standard operating procedure should (when used in conjunction with the trial/test protocol or other referenced information) contain all the information necessary to perform that task. SOPs should cover the full scope of the work carried out by the facility or organisation. This should include any procedure regularly carried out relating to the generation or retention of efficacy data or associated records. The level of detail in an SOP should reflect the level of training and competence of the staff using that SOP.

Example of required SOPs (for standard type efficacy trials work)

  1. Writing, reviewing, updating, distributing and controlling SOPs
  2. Trial/test protocol content and management (including procedures for recording amendments & deviations)
  3. Collection, handling and storage/archiving of raw test data (including procedures for collecting raw data and identification of the assessor, responsibility for the archive, the location of data, procedures for booking in and temporary removal of data from the archive and possibly a definition of raw data - ie data, calibration records, maintenance records, chemical store records, SOPs)
  4. Preparation of test substances/materials for application/treatment purposes
  5. Use, maintenance and calibration of test equipment (eg application equipment, balances, seed drills, combine harvesters). It is advisable to write separate SOPs for each type of equipment
  6. Selection criteria for choosing trial/test sites, including trial layout and site identification
  7. Collection of environmental and site specific data, relating to the trial/test site
  8. Trial/test assessment methodologies, plus procedures for recording deviations from those methods and any additional operations to be observed. These should include reference to any specific EPPO guidelines to be followed and/or any other expert keys/guidelines to be used
  9. Chemical control procedures (including unique identification of test substances & standards, booking in/out procedures, stock-taking and disposal procedures)
  10. The taking and archiving of photographs used to support efficacy trials

SOP Control

There should be someone responsible for the control and distribution of all SOPs. There should also be someone responsible for retaining the 'master copy' of all SOPs, including all current, superseded and retired SOPs. There needs to be a formalised distribution system for SOPs, along with a procedure for ensuring that superseded and retired SOPs are taken out of the system. SOPs should be reviewed regularly by appropriate staff. There should be a formalised system for amending SOPs between reviews. There should also be a system for 'activating' SOPs by means of an 'authorised signatory' and 'activation date' on each SOP.

Example (where re-issuing the SOP is unnecessary until scheduled review):

A typographical error has been spotted in SOP 04 'Assessment of Green Leaf Area'. This is not serious, so an e-mail is sent to all holders of SOP 04 to amend the SOP by hand, with the correct wording. This is then initialled & dated by the SOP holder, plus a note "as required by e-mail of 02/07/12 from BF".

Guidance on Writing Standard Operating Procedures (SOPs)

All SOP"s should be written in a clear and concise manner. The procedure should be described in simple, easy to understand and unambiguous text. The use of flow-charts may assist in highlighting the sequence in which actions take place. Each SOP should address the following topics for the defined activity;

Not all of these categories may be applicable to all SOP"s. However, it is essential that every SOP addresses WHAT, WHO and HOW.

SOP"s should contain:

A title; the objective; a unique SOP number; a version number; page numbers on every page (eg page 3 of 6); any appendices/attachments relating to the SOP; a copy number; an effective date; a "signed-off" date plus signature(s); a distribution list; a review date; and possibly a list of references to other documentation/related procedures

Each SOP should contain the following sections:

The purpose; the scope; an outline of the procedures; any references cited; the specific procedure.

SOP"s should be written in a style that, though providing a clear unambiguous description of the activity, still allows (where necessary), a degree of flexibility. This will be most relevant for SOP"s describing the use of equipment. Where possible, SOP"s should describe the operation of a generic equipment type, and not be restricted to a description of how to operate a specific model or make of such equipment.

Where the procedure indicates options for the conduct of a particular activity, the author must provide clear unambiguous guidance on the selection criteria the operator should use in making a decision.

SOP"s should act as management control tools, to ensure all activities are conducted in a manner which is acceptable with the aims of that facility/organisation and any compliance programmes they may relate to. It is management responsibility to "sign-off" SOP"s.

SOP"s should be prepared, where possible, by a person who will conduct the activity, or who is familiar with it. Regular review of SOP"s should be carried out by the management of the facility or organisation, to ensure that documented procedures continue to reflect current operational practice. Revision of SOP"s should be structured, although revisions may be identified through a number of routes; management review, audit, or operational activities (eg changes to practice). The responsibility for revisions to SOP"s rests with the management of the facility/organisation.

Further Information

Updated 2016-08-03