Purpose of SOP and its status (e.g. would failure to follow it be a disciplinary
offence?) should be stated at the top of the document.
Purposes may include procedures for delivery, dispatch, handling and storage of
cd’s. During production storage should include in process material. May also
include recruitment policy (cd store and other sensitive areas) staff searches, cctv
monitoring as well as tape management, key access and procedures, entry/exit
procedures to main warehouse and cd store, alarm activations, hostage
situations.
• The scope of the particular SOP should be stated (eg covers all matters relating
to cd’s)
• Some procedures may be subject to separate SOPs of their own eg. booking in,
despatch, stock checks & QA sampling. There should also be a separate SOP
covering emergency procedures such as fire, unauthorised entry, personal attack
etc.
• It should be clearly stated who within the company has overall responsibility for
cd’s and who for operational matters (may be the same person) The post having
responsibility for each must be clearly stated.
• If there is a security officer/manager or other security personnel on site their
roles, duties and responsibilities must be clearly defined.
1. Orders and arrangements for receipt of cd’s (to be agreed with suppliers)
It should be clearly stated who may place orders for cd raw materials/finished
goods & under what authority
There should be an agreed form(at) for ordering, preferably a single cd order
form
A second named postholder should check/authorise orders
Manual alterations to printed orders should not be allowed, except in the most
stringent of circumstances
There must be a proper record kept of orders (paper and/or computer)
Records of orders and confirmation of receipt of goods by customers should
be checked or audited at agreed intervals
In the case of all or significant orders, suppliers should be made aware of
identity of personnel who may order cd’s and the form of the orders
An agreement should be made with suppliers over delivery arrangements for
cd’s and this should be adhered to unless revised
Receiving company to know details of delivery i.e. time, vehicle, personnel &
contents (for large deliveries particularly)
2. Acceptance of deliveries & procedures on receipt
There should be agreed procedure for receipt of deliveries of cd raw material
& delivery vehicles brought on to site (eg checking drivers’ bona fides,
unloading vehicles behind closed doors by authorised personnel only).
There should be agreed procedures (including physical security) for returns
and deliveries/dispatches of other cd’s (eg through goods in not Reception)
There should be a visual check made of goods before acceptance and
before delivery is signed for
Drums/containers must be check weighed at earliest opportunity, gross
weights recorded and checked against tare record.
There should be an agreed procedure for delivering goods to secure storage
If discrepancies are discovered there must be a clear and agreed procedure
for reporting these to responsible person within the company, to the supplier
& to the Home Office Drugs Inspectorate within a specified time.
3. Procedures for accepting orders and cd dispatch
The bona fides and/or licensed status of customers must be confirmed
before any order for cd’s is accepted. The latter is particularly important for
suppliers of Schedule 1 (para 1b &1c compounds) cd’s
Cd’s should remain in the cd store or other agreed secure receptacle until
ready for dispatch
Cd’s should not be released to a delivery driver except in accordance with an
official order form
There should be a separate SOP for storage and delivery of cd’s from
delivery vehicle
This SOP should include clear instruction that deliveries should be signed for
by authorised person before being left
4. QC
SOP/agreed procedure for who has authority to break seals, take QC
samples and re-seal containers. Certain QC staff may need to be on list of
personnel authorised to enter cd store
Removal of sampling material by QC staff should be undertaken in the
presence of another member of that section
Samples should be recorded in an agreed manner (record kept in cd store &
QC lab
QC should have its own SOPs covering all their work including secure
storage facilities
QC will be involved at other stages, including production. SOPs should take
account of this. All QC practices will be covered by GLP.
5. CD Store (may be subject to separate SOP covering all aspects such as entry/exit
and alarm procedures)
If there is a cd store, those having access to it should be listed in an annex to
the SOP (not necessarily including managers). Access should be strictly
limited to essential personnel only
Certain unauthorised persons (visitors/contractors/HO inspectors) may be
allowed access but must be accompanied by an authorised person, who
should not leave the visitor unsupervised at any time
Those allowed accompanied access (HO inspectors/police etc) should be
listed and the circumstances under which they are allowed access should be
stated. Warrant cards/ID must be shown where appropriate.
Under no circumstances should staff, visitors, or contractors be allowed to
take bags, cases etc into the cd store
Persons authorised to hold keys to cd store should be listed in separate
annex along with secure location for keys when not in use
There should be a set procedure for handing over keys and returning same
The Cd Store alarm(s) should always be set when the store is unoccupied
It may be appropriate, for high security stores, to record entries (time, date &
personnel) to the store
Upon entry to the cd store the alarm must be turned off immediately
The circumstances under which the cd store may be opened and remain
opened with alarms unset should be set out
If there is a grill or day gate the circumstances under which it may be open
should be set out
If cctv is installed covering cd store it should be switched on at all times
It must be clearly set out who has responsibility for checking cctv monitors
Outside contact and procedures in emergency situations must be clearly
understood by all concerned
6. Recruitment policy
Licensees may wish to set up or take advantage of local arrangements with
police to vet prospective employees, particularly those working in sensitive
areas. Such employees may be asked to obtain a personal CRO check from
the police
All references from prospective employees should be taken up by Security
Officer/Manager or other manager
Personnel selected for cd store duties should have been with company for a
minimum period of time (12 months or more)
All new recruits should be asked to sign an agreement authorising personal
searches and searches of their means of transport (where applicable) by
approved company personnel (see also para 9). The company may wish to
consider the use of random drug testing for employees working with
controlled drugs
Particular care needs to be taken in the recruitment and use of agency staff.
The licensee will wish to satisfy themselves of the agency’s bona fides, as
well as its procedures for vetting potential candidates.
