Litmus Audits help all pharmaceutical clients / manufacturers are required to 'to ensure quality by establishing and implementing an effective pharmaceutical QA system, involving the active participation of the management and personnel of different services involved.

Litmus Audits can be customized to assess the effectiveness of this QA system and ensure that it complies with best manufacturing practices. Litmus Audits simple 4 step process offer client the flexibility to perform the audits by themselves (Licensed Service model), or outsource or contract the audit work to Litmus Infosec (Application Service provider model).Litmus Audit may be conducted of internal departments or externally by third party clients, audits may be conducted on a vendor/supplier/manufacturer by its customers or by a regulatory body (regulatory).

Internal audits

Internal audits are carried out by an organization on its own systems, procedures and facilities. Litmus offers integrated services that enable clients to increase management visibility of implementations and manufacturing practice and to propose any necessary corrective measures. We can also review the protocol records of such self-inspections and any subsequent corrective action be suggested.

The organization of internal audits depends on the size and complexity of the organization. A procedure and program of internal audits should be available and may be requested during regulatory audits. Responsibility for the management of internal audits should be assigned to ensure that they occur and are effectively followed up.

Litmus Audit services are offered in two models approach:

• Licensed Applications- audits carried out by the staff of a section or department on themselves.
• Audit Application Service provider - audits carried out by a corporate compliance group.


External Vendor/ Supplier audits

Litmus offers External audit services to help our client review and evaluate its vendors or subcontractors. These audits will assist pharmaceutical clients to get a thorough knowledge of their suppliers to ensure that contractors are competent to complete their assigned tasks, in accordance with GMP.

There are also strong business benefits to be derived from performing these audits:

• building knowledge and confidence in the partnership arrangement
• ensuring that requirements are understood and met
• enabling reduction of certain activities (eg in-house QC testing of starting materials)
• reducing the risk of failure (and, by implication, its costs)

Litmus audits realize that the scope of these audits will vary, depending on the relationship between the two parties, which may range from a simple vendor-purchaser transaction to a strategic joint venture partnership. We can review Confidentiality and technical agreements.

Regulatory Compliance audits

These audits are carried out by regulatory bodies against relevant regulations for the manufacture and supply of pharmaceutical products. National regulatory bodies, such as the Medicines Control Agency (MCA) in the UK and Food and Drug Administration (FDA) in the USA, are statutorily responsible for carrying out such audits. All licensed pharmaceutical manufacturers periodically receive them (as may their contractors). These audits may be unannounced as manufacturers are expected to be complying with GMP at all times. We also review compliance with Regulatory bodies from other countries in which products are sold.

Litmus Regulatory Compliance inspectors are extensively trained, knowledgeable and professional. Failure to pass a regulatory compliance audit can lead practical experience of GMP and receive suggestions how to ensure compliance with regulatory requirements. (FDA has recently imposed punitive financial 'consent decrees' on companies which failed to respond adequately to audit findings and comply with GMP.) Therefore, it is vital that companies have validated defined manufacturing processes and that staff are well trained and awareness of compliance requirements.

Regulatory audits vary considerably in scope, frequency and duration. Audits by the national regulatory body are likely to be regular and to cover systematically all areas of a facility, over a period of time. Depending on the scope, up to three inspectors may visit, for a period of between half a day to two weeks.

Litmus audit services, provide a formal executive report, the format of which can be customized to suit the client or the regulatory body concerned: Litmus Reports are brief, proactive, action-orientated, written reports identifying points of concern, followed by a more detailed establishment inspection report., suggesting corrective action to be undertaken place to ensure that timely and effective corrective action is taken.