1. The competent authority of the Member State concerned shall ensure, by means of repeated inspections, that the legal requirements governing medicinal products are complied with.
Such inspections shall be carried out by officials representing the competent authority who shall be empowered to:
(a) inspect manufacturing or commercial establishments and any laboratories entrusted by the holder of the manufacturing authorization with the task of carrying out checks pursuant to Article 20;
(b) take samples;
(c) examine any documents relating to the object of the inspection, subject to the provisions in force in the Member States on 21 May 1975 and which place restrictions on these powers with regard to the descriptions of the method of preparation.
2. Member States shall take all appropriate steps to ensure that the manufacturing processes used in the manufacture of immunological products are properly validated and attain batch-to-batch consistency.
3. After every inspection as referred to in paragraph 1, the officials representing the competent authority shall report on whether the manufacturer complies with the principles and guidelines of good manufacturing practice laid down in Article 47. The content of such reports shall be communicated to the manufacturer who has to undergo the inspection.