| Audit is an important event for those in | | | | bound to benefit those in manufacturing and |
| manufacturing of drugs. Traditionally Contract | | | | production, those that seek manufacturers for |
| Manufacturing Organisations were chosen for reasons | | | | contract, validation and compliance teams, and |
| like cost efficiencies, to decrease the time-to-market | | | | technical operation teams and of course the senior |
| or because the facility was not available in-house. | | | | management, who are faced with the arduous task |
| CMOs were thus involved in offering labor, equipment | | | | of choosing the right vendor. |
| and specific technologies. The economies of countries | | | | How to choose the correct vendor and ensure that |
| like India and China are growing to sizable proportions, | | | | the vendor complies with agreed specifications is a |
| due to the benefits of contract manufacturing that | | | | huge challenge. Quality is the number one concern, |
| these specific countries, and others like them, offer. | | | | but even established players in market may not be |
| Contract manufacturing is gaining more and more | | | | adequately skilled or prepared to assess quality |
| importance these days, especially after the recession | | | | standards in vendors accurately every time. This calls |
| last year. In addition to the traditional benefits, more | | | | for continuous training and upgradation in skills of the |
| recently, companies are outsourcing to CMOs so that | | | | auditor and the auditing team. The auditors should be |
| they can be able to concentrate on marketing and | | | | induced to define specifications, like reference |
| business development. Seen once as a strategy | | | | standards, impurity standards, bioburden, particle size, |
| adopted mostly by European and US-based | | | | and so on. One should know the product and material |
| multi-national companies, Contract Manufacturing is | | | | specifications, quality control, change specifications, |
| increasingly being adopted by all level of companies, | | | | packaging configuration, delivery conditions, |
| for its obvious benefits. | | | | sub-contracting, etc. Above all, regulatory |
| It has always been essential to ensure the quality | | | | requirements, in terms of Material, Manufacturing, |
| and compliance of suppliers providing GMP related | | | | leading to overall quality should be met. |
| materials for manufacturing. Companies look for GMP | | | | Technical details are not the only pre-requisite for |
| certified manufacturers who can offer quality, in the | | | | Contract manufacturing arrangements; the |
| most efficient timeframes. Also there is a need for | | | | commercial details are very often critical, and key to |
| quality testing, storage of APIs, drug products, | | | | the success of the arrangement. What is a good |
| excepients & packing materials. In effect, both | | | | agreement - certainly one that meets requirements |
| quality and commercial criteria dictate the choice of | | | | of both the parties to make a cohesive association. |
| vendors. | | | | Clearly, we need to be trained on how to make and |
| In order to get maximum leverage of Contract | | | | sustain a good agreement. Once an audit is done, is it |
| Manufacturing, it is imperative to focus on critical | | | | viable enough to last for the whole tenure of the |
| business issues; How to decide if a contract | | | | association/agreement? It would be ideal to have the |
| manufacturer has desired qualifications, how to | | | | audit repeated periodically. If an auditor with needed |
| ensure that we can have best manufacturers, who | | | | expertise is not available in-house, one looks for |
| can scrutinize this and what should this auditor | | | | external auditors. How to choose an auditor in such |
| auditing team look for, etc. | | | | cases and what should be the criteria of choosing |
| With the level of contract manufacturing increasing, | | | | one and making an agreement for the same. |
| Audit of CMOs is now becoming critical for drug | | | | It is hoped that the conference will help analyze and |
| companies. In view of this, the upcoming conference | | | | understand the process and criteria of choosing a |
| on audits, which is being organized by Prescription | | | | CMO and how to be a good auditor. Much beyond |
| Pharma Support, has a session in agenda dedicated | | | | inspection and giving an opinion, audit of CMOs |
| to discussing the audits and choice of CMOs. The | | | | involves extending support to them to help them |
| discussion is truly desired as audit is much beyond a | | | | develop and design what is desired! |
| regulatory inspection by FDA, EU or MHRA. This is | | | | |