Site master file report

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Mainly they provide guidelines for sterile pharmaceutical guidelines. They also provide quality assurance guidelines as the market complaint, product recalls etc.

Pre and post admission study team meetings SOP. Subject visit log any trial. Blood Sampling SOP. Subject withdrawal and termination log. Pre-screening eligibility check template. Transfer of patients SOP. Screening procedures. Interviewer recruitment log. Participant communication log. Interviewer follow up form.

Informed consent template - generic. Audiovisual recording of informed consent SOP. Informed consent template for clinical trials. Reviewing and obtaining informed consent SOP.

Informed consent template for observational in-patient clinical trials. Informed consent template for interviewing research studies. Informed consent template sampling only.

Monitoring informed consent checklist. Subject informed consent log template. AudioViual recording informed consent checklist. Opinion leader inputs - meeting records. Informed Consent Sample only in household community. Concomitant medication log. Managing biological samples SOP. Preparation for clinical conduct SOP. Drug accountability log template.

Drug supplies record template. Acknowledgement of IMP receipt template. Pharmacy Accountability form template. Packing of IMP form template. Investigator IMP accountability form. IMP return form template.

Receipt for IMP destruction. IMP Temperature log. Lab selection form. Data handling study team agreement. Data Recording SOP. Data clarification form. Data management plan. CRF template -generic malaria. CRF template generic. CRF tracking template. Trial contacts sheet. Logs List Template. Keeping protective clothing inside areas where products with special risk of cross-contamination are processed.

Using cleaning and decontamination procedures of known effectiveness, as ineffective cleaning of equipment is a common source of cross-contamination. If equipment is dedicated to manufacturing one intermediate or API, then individual equipment records of different activities like cleaning, maintenance, batch log, etc. In case of formulation manufacturing, the appropriate cleaning procedure should be established to ensure removal of any residue of the previous product.

The results of any test or examination performed and the conclusions derived from this;. Documentation of the examination and review of labeling and packaging materials for conformity with established specifications;. The final decision regarding rejected raw materials, intermediates, or labeling and packaging materials.

Starting materials in the storage area should be appropriately labeled. Labels should bear at least the following information:. The batch number given by the supplier and, on receipt, the control or batch number if any given by the manufacturer; these must be documented so as to ensure traceability. The status of the contents e. Master approved labels should be maintained for comparison with issued labels. Competent persons experienced in production and quality control should be responsible for the content and distribution within the firm of instructions and master formulae.

These should be duly signed and dated. Outdated master formulae should be withdrawn but retained for reference. Copies of the master formula should be prepared in a manner that will eliminate any possibility of transcription error. In certain circumstances, for example, in the first production runs following pilot development, the master formula might need to be amended. Any amendments must be formally authorized and signed by competent person s.

The amended document should be replaced at the earliest opportunity by a newly prepared master formula. Processing should be carried out in accordance with the master formula. Master production instructions should include:. A complete list of raw materials and intermediates designated by names or codes sufficiently specific to identify any special quality characteristics.

An accurate statement of the quantity or ratio of each raw material or intermediate to be used, including the unit of measure. Where the quantity is not fixed, the calculation for each batch size or rate of production should be included. Variations to quantities should be included wherever justified. Where appropriate, special notations and precautions to be followed, or cross-references to these. The batch production record should be checked before issuance to assure that it is the correct version and a legible accurate reproduction of the appropriate master production instruction.

If the batch production record is produced from a separate part of the master document, that document should include a reference to the current master production instruction being used.

Before any processing begins, a check should be performed and recorded to ensure that the equipment and workstation are clear of previous products, documents, or materials not required for the planned process and that the equipment is clean and suitable for use. These records should be numbered with a unique batch or identification number and dated and signed when issued.

In continuous production, the product code together with the date and time can serve as the unique identifier until the final number is allocated.

The batch number should be immediately recorded in a logbook or by electronic data processing system. The record should include date of allocation, product identity, and size of batch. Documentation of completion of each significant step in the batch production records batch production and control records should include:. Specific identification of each batch, including weights, measures, and batch numbers of raw materials, intermediates, or any reprocessed materials used during manufacturing.

Signatures of the persons performing and directly supervising or checking each critical step in the operation. Any deviation noted, its evaluation, and investigation conducted if appropriate or reference to that investigation if stored separately.

All analytical records relating to the batch, or a reference that will permit their retrieval. A decision for the release or rejection of the batch, with the date and signature of the person responsible for the decision. Production and quality control records should be reviewed as part of the approval process of batch release. Any divergence or failure of a batch to meet its specifications should be thoroughly investigated.

The investigation should, if necessary, extend to other batches of the same product and other products that may have been associated with the specific failure or discrepancy. A written record of the investigation should be made and should include the conclusion and follow-up action.

The following information should be recorded at the time each action is taken the date must be noted and the person responsible should be clearly identified by signature or electronic password :.

The name of the product, the batch number and the quantity of product to be packed, as well as the quantity actually obtained and its reconciliation. The checks made for identity and conformity with the packaging instructions, including the results of in-process controls. Details of the packaging operations carried out, including references to equipment and the packaging lines used and, when necessary, instructions for keeping the product unpacked or a record of returning product that has not been packaged to the storage area.

Whenever possible, the regular check for correctness of printing e. Notes on any special problems, including details of any deviation from the packaging instructions, with written authorization by an appropriate person.

The quantities and reference number or identification of all printed packaging materials and bulk product issued, used, destroyed, or returned to stock and the quantities of product obtained; this is necessary to permit an adequate reconciliation. Laboratory control records should include complete data derived from all tests conducted to ensure compliance with established specifications and standards, including examinations and assays, as follows:. A statement of the weight or measure of sample used for each test as described by the method; data on, or cross-reference to, the preparation and testing of reference standards, reagents, and standard solutions.

A complete record of all raw data generated during each test, in addition to graphs, charts, and spectra from laboratory instrumentation, all properly identified to show the specific material and the batch tested. A record of all calculations performed in connection with the test including, for example, units of measure, conversion factors, and equivalency factors. A statement of the test results and how they compare with established acceptance criteria.

The signature of the person who performed each test and the date s on which the tests were performed. The date and signature of a second person, showing that the original records were reviewed for accuracy, completeness, and compliance with established standards.

Periodic calibration of laboratory instruments, apparatus, gauges, and recording devices. Complete records should be maintained of any testing and standardization of laboratory reference standards, reagents, and standard solutions; record should also be maintained of periodic calibration of laboratory instruments, apparatus, gauges, and recording devices.

Written procedures should be established and followed for the review and approval of batch production and laboratory control records, including packaging and labeling, to determine compliance of the intermediate or API with established specifications before a batch is released or distributed.

Batch production and laboratory control records of critical process steps should be reviewed and approved by the quality unit s before an API batch is released or distributed.

Production and laboratory control records of non-critical process steps can be reviewed by qualified production personnel or other units, following procedures approved by the quality unit s. All deviation, investigation, and OOS reports should be reviewed as part of the batch record review before the batch is released. The quality unit s can delegate to the production unit the responsibility and authority for release of intermediates, except for those shipped outside the control of the manufacturing company.

Distribution record should be maintained and must include the batch number; quantity produced; name, address, and contact details of customer; quantity supplied; and date of supply.

Think about what happens in a workplace if written procedures are not available. People rely on more senior employees to tell them how to do things and then do their job from memory.

This is fine for a company making garden pots, but not so good when the products being made are pharmaceuticals and can even cause death! In the food, drug, and medical device industry it is critical that good procedures are in place to ensure a controlled and consistent performance; it is an essential part of GMP.

Procedures should be clear, concise, and logical. Consider hiring a professional technical writer to do the job. Unlike permanent employees, they know how write well and will perform usability tests to ensure that the documents work. Review of procedure by an independent party can also help to improve process. Outline the task before you begin writing the procedure.

Create a brief breakdown of the important steps and key points related to the task; a flowchart is a useful tool. Remember that people do not usually read procedures from start to finish; they tend to scan the document for key words.

To make information easier to digest and follow, break the procedure into chunks and use the following:. When writing out any procedure, one should try and visualize the person who will be following that procedure. Use language that that person can understand. Do not include too much or too little information. Increase the readability of the instructions by using simple sentences and by writing in a conversational style. Most companies have a 3-year review cycle for their documents; however, this can be set according to the likelihood of change in the process that the document relates to.

It is all very well to have great written procedures in place but to ensure a controlled and consistent performance they need to be followed; it is a GMP requirement. Frequently, the steps described in a written procedure may not appear to be the most efficient way of working. Taking shortcuts may save time or make the task easier, but one should never deviate from a written procedure without the approval of a supervisor or the quality department.

NET 3. If you have not yet upgraded to ASP. NET 2. However, some demo applications may use features new to the. NET Framework version 3. Do keep in mind that the demo applications available for download from each tutorial target the. NET pages' code-behind classes. Long story short, if you have yet to install. See Dissecting ASP. NET Version 3. You will also need to remove the using statements that reference 3. Before we can explore creating and using master and content pages, we first need an ASP.

NET website. Start by creating a new file system-based ASP. Choose the ASP. This will create a new web site with a Default. I use the Web Site Project model for my demos in this tutorial series. If you are using a non-Express edition and want to use the Web Application Project model instead, feel free to do so but be aware that there may be some discrepancies between what you see on your screen and the steps you must take versus the screen shots shown and instructions provided in these tutorials.

Next, add a master page to the site in the root directory by right-clicking on the Project name, choosing Add New Item, and selecting the Master Page template. Note that master pages end with the extension. Name this new master page Site. Adding a new master page file through Visual Web Developer creates a master page with the following declarative markup:.

The first line in the declarative markup is the Master directive. NET pages. It defines the server-side language C and information about the location and inheritance of the master page's code-behind class. The page includes static HTML along with four server-side controls:. This default master page declarative markup serves as a starting point for designing your own master pages. When designing a master page make sure that the master page contains a Web Form and that at least one ContentPlaceHolder control appears within this Web Form.

Let's expand Site. NET" icon. Figure 6 shows the end result of the master page when one of its content pages is viewed through a browser.

The red circled region in Figure 6 is specific to the page being visited Default. To achieve the site layout shown in Figure 6, start by updating the Site.

NET" icon, respectively. If you are following along at your computer, you will need to download this tutorial's accompanying code and add the Styles. NET" icon from the downloaded demo website to your project. A discussion of CSS and web page formatting is beyond the scope of this article. I also encourage you to download this tutorial's accompanying code and play with the CSS settings in Styles. Over the years I've built a number of ASP. NET web applications for small- to medium-sized companies.

Some of my clients had an existing site layout they wanted to use; others hired a competent graphics designer. A few entrusted me to design the website layout. As you can tell by Figure 6, tasking a programmer to design a website's layout is usually as wise as having your accountant perform open-heart surgery while your doctor does your taxes.

Fortunately, there are innumerous websites that offer free HTML design templates - Google returned more than six million results for the search term "free website templates. Once you find a website template you like, add the CSS files and images to your website project and integrate the template's HTML into your master page.

Microsoft also offers a number of free ASP.