| In order to assure that a company has a well | | | | review & approval, and calibration is also done as this |
| functioning organizational structure executive | | | | may change based on use. Every written procedure |
| management needs to be very proactive. No where | | | | must be sufficiently detailed and accurate to make |
| is this more the case than in the QC laboratory | | | | sure that it is operated satisfactorily.. |
| environment. | | | | 4. The documentation |
| Audits and warning letters are very common within | | | | This is the way to record how a product is produced, |
| the pharmaceutical industry, and issues connected | | | | tested, packaged and stored, so, all documentation |
| with both of these are very common in dealing with | | | | must be clearly identified and complete. Every |
| laboratory operations. Given the complexity of QC | | | | procedure must be clearly documented to ensure |
| operations, situations where this is under control is | | | | controlled use and any implementation of planned |
| impressive given the criticality relative to drug | | | | changes. Procedures should reflect the actual |
| development processes. | | | | practices and must govern the quality and integrity |
| There are regulations to ensure that the products | | | | of the data being produced to support the product. |
| comply with certain standards of safety, efficacy, | | | | Every change, no matter how small, must be |
| purity, and stability. These regulatory inspections are | | | | immediately documented. |
| conducted anytime, without warning by the FDA, | | | | |
| thus, laboratories must perform regular | | | | 5. The laboratory records |
| self-evaluations to ensure they meet the regulatory | | | | These must be current, permanent, legible, accurate, |
| standards. | | | | clear, consistent, and complete. Work that is not |
| Following are several basic elements of a laboratory | | | | documented was never performed. Records must |
| control system that ensure the production of | | | | include the 'what' and 'how' of the matter, and regular |
| high-quality products: | | | | reviews must be performed to assure their accuracy, |
| | | | showing the signatures of those who were |
| 1. The facility | | | | responsible for the tasks. Electronic records must |
| It should be of the right size and design To function | | | | exist as a back up. |
| with a good product and personnel flow. | | | | 6. The materials and methods |
| The operators must pay close attention to and | | | | Every single material must be described and verified |
| permanently monitor airflow, temperature and | | | | for quality and acceptability. The identity and |
| humidity conditions to ensure all laboratory operations | | | | concentration of reagents must be documented and |
| are carried out under a controlled environment. Work | | | | labeled, as well as storage requirements and |
| areas must be spotlessly clean at all times. Test | | | | expiration dates. All suppliers must be qualified and |
| articles must be separated to make sure samples are | | | | approved. If, at any time, a manufacturer can't |
| not contaminated or stressed, as well as not mixed | | | | supply a specific reagent, equivalent alternates are |
| or handled incorrectly. | | | | needed for specific branded products utilized in |
| | | | procedures. The transfer of materials must be |
| 2. The equipment | | | | documented as well, and every product has to be |
| There should be enough space for both existing and | | | | identified by proper labels. Materials and methods |
| new equipment. Every piece of equipment must be | | | | have to ensure the product is free from |
| accurately qualified for its use purpose and must be | | | | contamination and deterioration. Reference material |
| regularly calibrated and maintained to ensure that the | | | | must be completely characterized and documented, |
| results are accurate and valid. Maintenance must be | | | | well-stored, secured, and used during testing. |
| based upon standard operating procedures and | | | | 7. The training |
| manuals. Equipment with critical status has to be | | | | All personnel must be highly-qualified and experienced |
| given high priority in relation to preventive | | | | to perform the job. General as well as functional |
| maintenance and calibration, and must be fully | | | | training must be validated.training should include a |
| qualified and validated. Other types of equipment | | | | thorough knowledge of cGMP practices. |
| may require qualification or validation, depending on | | | | 8. The laboratory investigations |
| their use. | | | | These should identify the causes of a problem, and |
| 3. The Validation | | | | should include initial observations, immediate actions, |
| Every laboratory process must be qualified & | | | | and correction, to ensure the issue doesn't happen |
| validated; this includes facilities, equipment, analytical | | | | again. Where necessary,investigators should dispose |
| methods, and computer programs used to test | | | | of the affected products and issue a formal report |
| pharmaceutical products. Every supplier needs to be | | | | on the case. Future inspections must be performed |
| audited and qualified And should be part of an | | | | to check that everything is back to normal. |
| approved vendor process. | | | | Be practical and look for the necessary information |
| The validation includes many qualification activities | | | | and advice from a pharmaceutical consultant before |
| that ensure every process has complied with its | | | | you and your image have something to regret. |
| pre-determined acceptance criteria. It has | | | | Better safe than sorry! |
| documented testing performed under strictly | | | | If you liked this article, tell all your friends about it. |
| controlled conditions, confirming a mode of operation | | | | They'll thank you for it. If you have a blog or |
| that provides a consistent result. Revalidation is | | | | website, you can link to it or even post it to your |
| necessary at defined intervals or every time a | | | | own site (don't forget to mention as the original |
| validated system changes subject to change control | | | | source). |