SERVICES

GOOD DOCUMENTATION PRACTICES (GDPs)

 

 

We can assist you to establish the needed Standard operating procedures and all other documents pertaining to Good Manufacturing Practices and Good Clinical Practices

 Our documents were written according to the FDA, Health Canada, ICH, and WHO Guidelines

 DEFINITION (WHAT IS A DOCUMENT?)

The document is information (meaningful data) and its supporting medium, which could be in paper form, CD, computer files, or microfilm.

When an organization develop (establish), and keep documents that describe (1) how the Quality Management System is applied to a specific product, (2) establish documents on product requirements (specifications), (3) establish documents to provide information about how the facility perform activities and processes (procedures), and (4) establish documents to provide objective evidence performed or results achieved (records), then the organization management can claim that they fulfill the Good Documentation Practices requirements.

Good Documentation Practices, in brief, enable communications of intent and consistency of actions (ISO-9000: 2000).

FUNDAMENTALS

 

DOCUMENTS PURPOSES 

The purposes of Good Documentation (as set out in the WHO Good Manufacturing Practices guidelines for Pharmaceutical products) are:

1. To define the specifications and procedures for all materials and methods of manufacture and control

2. To ensure that all personnel concerned with manufacturing know what to do and when to do it.

3. To ensure that authorized persons have all the information necessary to decide whether or not to release a batch of a drug for sale.

4. To ensure the existence of documented evidence, traceability, and to provide records and an audit trail that will permit investigation.

5. And to ensure the availability of the data needed for validation, review, and statistical analysis.

DOCUMENTS TYPES (CATEGORIES)

The following are the types of documents, which organization should establish and keep:

1. Guideline: To provide recommended practices and instructions.

2. Policy: Is a document to establish the organization interpretation and attitude toward the regulatory body.

3. Standard Operating Procedure (SOP): To provide detailed instructions on how to implement a process or perform a specific activity. 

4. Record: Is a document, stating results achieved or providing evidence of activities performed.

5. Forms and Templates: Are a pre-structured document with blank spaces designed for insertion of required information.

6. Manual: To provide information on how a system or equipment operate.

DOCUMENTS FORMAT (AND MANAGEMENT)

1. Documents should be designed, prepared, reviewed and distributed with care

2. Documents should be approved, signed and dated by the appropriate responsible persons. No document should be changed without authorization and approval.

3. Documents should have unambiguous contents: the title, scope, and purpose should be clearly stated.

4. Design and use of documents depend upon the corporate

5. Documents should be regularly reviewed and kept up to date.

6. Where documents require the entry of data, these entries should be clear, legible, and indelible.

7. Any alteration made to a document should be signed and dated; the alteration should permit the reading of the original information. 

8. Records should be made or completed when any action is taken and in such a way that all significant activities concerning the manufacture of pharmaceutical products are traceable.

9. Records should be retained for at least one year after the expiry date of the finished product.

10. Data (and records for storage) may be recorded by electronic data-processing systems or by photographic or other reliable means.

11. Master formula and detailed standard operating procedures relating to the system in use should be available and the accuracy of the records should be checked.

12. If documentation is handled by electronic data-processing methods, only authorized persons should be able to enter or modify data in the computer, and there should be a record of changes and deletions.

13. Batch records stored electronically should be protected by back-up transfer on CD, microfilm, paper print-outs or other means. It is particularly important that, during the period of retention, the data are readily available.

REQUIRED DOCUMENTS

As indicated in WHO general principles of GMPs guideline for pharmaceutical products, the plant management should ensure that the following documents are prepared and available:  

1. Specifications including tests on identity, content, purity and quality for starting and packaging materials and specifications for intermediate, finished, and bulk products.

2. Specifications for water, solvents and reagents (e.g. acids and bases) used in production.

3. Pharmacopoeias, reference standards, and other reference materials should be available in the quality control laboratory.

4. A formally authorized master formula should exist for each product and batch size to be manufactured.

5. Formally authorized packaging instructions should exist for each product, pack size and type.

6. A batch processing record should be kept for each batch processed.

7. Before any processing begins, a check should be made and recorded. (That the equipment is clean and work station are clear of previous products, documents, or materials not required for the planned process) 

8. A batch packaging record should be kept for each batch or part batch processed. 

9. Batch number allocation should be recorded, e.g. in a log­book. 

10. Analysis records, the tests performed should be recorded

11. Records should be maintained of the distribution of each batch of a product in order to facilitate the recall of the batch if necessary.

12. Records should be kept for major and critical equipment of any:

• Validations and Calibrations

• Maintenance and repair operations and cleaning 

13. The use of major and critical equipment and the areas where products have been processed should be recorded in chronological order.

14. Standard operating procedures and associated records of actions taken should be available for:

• Equipment assembly and validation

• Analytical apparatus and calibration

• Maintenance, cleaning, and sanitization

• Personnel matters including qualification, training, and hygiene

•  Environmental monitoring

• Pest control and assigning responsibility for cleaning and sanitation

• Written release and rejection procedures

• Complaints, Recalls, Returns and Sampling

• For testing materials and products at different stages of manufacture describing the methods and equipment to be used.

• For describing the details of the batch (lot) numbering system

• For the internal labelling, quarantine and storage of starting materials, packaging materials and other materials

• For the receipt of each delivery of starting material and printed packaging material.

To apply the above fundamentals to actual regulations as described in the current GMPs guidelines, we present herein the documentation requirements as indicated in the FDA Dietary Supplement Rules,  compared with Health Canada; Natural Health Products GMPs documentation requirements.

 

FDA DIETARY SUPPLEMENT RULES

As a background information, on June 22, 2007, FDA announced a final rule establishing Good Manufacturing Practice requirements for dietary supplements. The final rule on GMPs is a critical component of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

This rule helps to ensure the quality of dietary supplements. According to the rule, the compliance date is 12 months after publication in the Federal Register, while businesses with fewer than 500 but more than 20 employees will have 24 months, and business of fewer than 20 employees will have 36 months.

 

FDA Vs HEALTH CANADA DOCUMENTATION REQUIREMENTS

The new FDA final rule on GMPs for dietary supplements, require the facility management to develop (make available) written procedures and records for almost every single activity in the facility.

Also, as per the natural health products GMPs guidance document, Health Canada (HC) requires manufacturers to retain in the premises 16 types of records. The absence of any of these records will be considered a deviation from the GMPs regulations, which may result in a non-compliant rating.  

 

Table (1) contains a list of documents that needed by US FDA and HC as guidance. The mark (√) in front of the document title means that the document is required.

 TABLE (1)

GMPs DOCUMENTS NEEDED BY USA FDA AND HEALTH CANADA

QMRS DOCUMENTATION SUPPORT

QMRS Documents Characteristics and Benefits

1. These documents are in the Ready to Use form (MW). Thus, very little adjustments (changes) required to suit your organization

2. QMRS can provide you with all the needed policies, guidelines, SOPs, forms, and audit check lists. This will assure consistency in style and format

3. Since writing these documents requires a great deal of time, skills, and resources, certainly, you will save countless hours and days of your employee’s time for searching and writing.

4. You will make advantages of our professionally researched and written documents.

5. Enjoy free consultation by email. This will include free updating (if any) of any SOP within one year of purchasing the document (This service is upon your written request).

6. Please click on the document title inside the tables or visit the ON-LINE PURCHASE page to learn more on how to obtain these documents.

7. We offer an easy and secure credit card payment via, Pay Pal, by Cheque, or bank transfer in Canadian or US Dollar.

QMRS Standard Operating Procedures And Policies 

Table (2) contains a list of policies and procedures, which are available in our On-line store. These SOPs cover the most important aspects of health products GMPs. In table (3), you will find the available SOPs on almost all activities pertaining to clinical trials.

Please click on ON-LINE PURCHASE or on the document title inside the following tables to learn more on the purpose and price of the document. Also, if you have a question or could not find a specific document, please do not hesitate to contact us. Just send us your request to info@qmrs.com and promptly, we would be pleased to answer you.

To make you more confident about our products, please click SOP Sample to review a sample of our procedures.

 

Audit Checklists

Under Site License Section support (GMPs Audit), we discussed the three types of audit (First Party. Second Party and Third Party audit). As it was indicated, First Party audit is performed within the organization by its own employees. The objective is to assure development, maintenance, and improvement of the facility quality system in order to fulfill the applicable regulations. From the regulations requirements perspective, the audit checklist is a valid document to prove that the “internal audit program” is in place.

Therefore QMRS developed a number of auditing checklists, which are ready to purchase on-line.

Forms and Templates

As indicated above, FDA, WHO, and Health Canada require many types of records, which should be maintained in the manufacturers’ site.

QMRS designed/prepared a number of templates and forms to suit the industry need. If you need any assistance in this regard, please do not hesitate to call us on 613 526 0471, or write to info@qmrs.com to learn more about all other available documents.     

 

   TABLE (2):

AVAILABLE STANDARD OPERATING PROCEDURES AND POLICIES ON

Good Manufacturing Practices (GMPs)

NOTE: PLEASE CLICK ON THE DOCUMENT TITLE FOR MORE INFORMATION

TABLE (3):

AVAILABLE STANDARD OPERATING PROCEDURES AND POLICIES ON

GOOD CLINICAL PRACTICES (GCPs)

NOTE: PLEASE CLICK ON THE DOCUMENT TITLE FOR MORE INFORMATION