Documentation
1. Documentation shall meet the following requirements:
(a)
be readily available or retrievable;
(b)
be sufficiently comprehensive with respect to the scope of the activities of the persons referred to in Article 1(2);
(c)
be written in a language understood by personnel;
(d)
be written in clear, unambiguous language.
2. When errors in the documentation are identified, they shall be corrected without delay, with clear traceability of who corrected them and when.
3. Any alteration made in the documentation shall be signed and dated. The alteration shall permit the reading of the original information. Where appropriate, the reason for the alteration shall be recorded.
4. Each employee shall have ready access to all necessary documentation for the tasks executed.
5. All documentation related to compliance of the persons referred to in Article 1(2) with good distribution practice for active substances used as starting materials in veterinary medicinal products as laid down in this Regulation shall be made available on request of competent authorities.
6. Relationships and control measures for original documents and official copies, data handling and records shall be stated for all paper-based, electronic and hybrid systems.
Procedures
1. Procedures shall describe the distribution activities affecting the quality of the active substances used as starting materials in veterinary medicinal products. Those activities include:
(a)
receipt and checking of deliveries;
(b)
storage;
(c)
cleaning and maintenance of the premises, including pest control;
(d)
recording of the storage conditions;
(e)
security of stocks on site and of consignments in transit;
(f)
withdrawal from saleable stock;
(g)
handling of returned active substances used as starting materials in veterinary medicinal products;
(h)
recall plans.
2. Procedures shall be approved, signed and dated by the relevant person responsible for the quality system.
3. Valid and approved procedures shall be used. Documents shall be clear and appropriately detailed. The title, nature and purpose of documents shall be stated. Documents shall be reviewed regularly and kept up to date. Version control shall be applied to procedures. After revision of a document, a system shall exist to prevent inadvertent use of the superseded version. Superseded or obsolete procedures shall be removed from workstations and archived.
Records
1. Records shall be clear, made at the time each operation is performed and in such a way that all significant activities or events are traceable.
2. Records shall be retained for at least 1 year after the expiry date of the active substance batch to which they relate. For active substances with retest dates, records shall be retained for at least 3 years after the batch is completely distributed.
3. Records shall ensure the traceability of the origin and destination of active substances used as starting materials in veterinary medicinal products, in order to identify all the suppliers of, or those supplied with those active substances. Records shall be kept of each purchase and sale. Records that shall be retained and be available include:
(a)
the date of the transaction;
(b)
name or designation of the active substances used as starting materials in veterinary medicinal products;
(c)
original active substance manufacturer’s batch number;
(d)
quantity received or supplied;
(e)
retest date or expiry date;
(f)
name or company name and permanent address or registered place of business of the supplier and of the original active substance manufacturer, if not the same, or of the shipping agent or the consignee;
(g)
purchase orders;
(h)
bills of lading, transport and distribution records;
(i)
receipt documents;
(j)
certificates of analysis, including those of the original active substance manufacturer;
(k)
any additional requirements specified by national law.
