PDF《(THR 20894/0071)》

500 mg of standardised dry extract from Milk thistle fruit and Milk Thistle Tablets contain

125 mg of standardised dry extract from Milk thistle fruit. The tablet cores of these tablets are composed of calcium carbonate, maltodextrin, croscarmellose sodium, microcrystalline cellulose, colloidal anhydrous silica and magnesium stearate. The tablets are coated in hypromellose and purified talc. The compatibility of the herbal preparations with the excipients is demonstrated by the stability testing results. The excipients are controlled in line with their respective Ph Eur monograph. The magnesium stearate used in the products is confirmed to be of vegetable origin. Certificates of Analysis have been provided for all excipients. Manufacture A flow diagram outlining the various stages of the manufacturing process and the in- process controls is provided. In-process controls are appropriate considering the nature of the products and the method of manufacture. Currently, process validation has not been carried out on commercial batches, however, as the manufacturer has committed to carry out process validation on commercial batches following an appropriate process validation protocol, this is acceptable. Control of Herbal Products The finished product specifications are satisfactory. Acceptance limits have been justified with respect to conventional pharmaceutical requirements and, where appropriate, safety. Test methods have been described and have been adequately validated, as appropriate. Batch data have been provided and comply with the release specification. MHRA PAR;

GERARD HOUSE MAX STRENGTH MILK THISTLE TABLETS (THR 20894/0071) AND GERARD HOUSE MILK THISTLE TABLETS, HERBALSTORE MILK THISTLE TABLETS AND WILKO MILK THISTLE TABLETS (THR 20894/0072)

7 Container Closure Systems The tablets are sealed into PVC/PVDC aluminium foil blisters that are inserted into a carton. Each carton contains 30,

60 or

120 tablets. Suitable specifications have been provided by the packaging suppliers and it has been confirmed that all primary packaging materials comply with current legislation relating to plastic materials and articles intended to come into contact with foodstuffs. Stability Finished product stability studies have been conducted in accordance with current guidelines. Based on the results, a product shelf-life of

24 months is appropriate when the storage precautions '

Do not store above 25° C'

and '

Store in the original package'

are applied. Pharmaceutical Expert The Quality Overall Summary has been written by a suitably experienced expert. Summaries of Product Characteristics, Labels and Patient Information Leaflets All product literature is satisfactory. A package leaflet has been submitted to the MHRA along with results of consultations with target patient groups ( user testing ), in accordance with Article

59 of Council Directive 2001/83/EC. The results indicate that the package leaflet is well-structured and organised, easy to understand and written in a comprehensive manner. The test shows that the patients/users are able to act upon the information that it contains. CONCLUSION There are no objections to granting of Traditional Herbal Registration Certificates from a quality point of view. MHRA PAR;

GERARD HOUSE MAX STRENGTH MILK THISTLE TABLETS (THR 20894/0071) AND ........