Standard operating procedures in pharmaceutical quality systems

Objective: To develop explanatory texts for a pharmacy curriculum and reference textbook and to develop model standard operating procedures (SOP s) on key quality and operational pharmaceutical activities. Method: Explanatory texts were written and model SOP s were developed. Emphasis on clarity, conciseness and user-friendliness was made when selecting the writing style and format of the documents. Key Findings: Three explanatory texts entitled ‘Master Standard Operating Procedure’, ‘Preparing a Standard Operating Procedure’ and ‘Good Manufacturing Practice’ were compiled and sixteen model SOPs were developed. Conclusion: Effective SOPs are required to achieve compliance with regulatory requirements and good practice guidelines. Explanatory texts and model SOP s are provided to assist in the development of a pharmaceutical quality management system. The texts developed are an effective training tool on the development of good quality SOPs and the model SOPs are an example of the good quality procedures being recommended.peer-reviewe

Quality risk management implementation for a medicinal products wholesale dealer

OBJECTIVES: The aims of this study were to compile a model of a Quality Management System (QMS ) for distribution of medicines, identify the risks in distribution to the quality of medicinal products from a Maltese wholesale dealer’s perspective and evaluate these risks using Quality Risk Management (QRM) methodology. The ultimate objective was to indicate whether risks are being well managed and to propose appropriate corrective and preventive actions (CAPA). METHOD: A set of model Standard Operating Procedures (SOPs) which describe the current wholesale dealer’s operations was compiled. These SOPs were written in simple English to facilitate comprehensiveness by the employees. The various steps in the distribution of medicinal products by a wholesaler and the risks in each step were identified and a flowchart was compiled. A QRM assessment was carried out, taking into consideration current risk management activities described in SOPs. No further action was recommended for risks which were deemed as acceptable, however appropriate CAPA was recommended for risks deemed as being unacceptable. KEY FINDINGS: Out of 70 identified risks during QRM evaluation, 65 risks were deemed acceptable, while 5 were deemed not acceptable. Areas exhibiting unacceptable risks were ‘Returns of medicinal products’ (1 risk) and ‘Temperature monitoring and control during shipment from supplier’ (4 risks). CONCLUSION: CAPA was proposed to change the profile of unacceptable risks. A model QRM SOP was compiled to be used by Maltese wholesale dealers in setting up a QRM system and to help in fulfilling regulatory obligations.peer-reviewe

Compliance with protocols in dental conditions

The aims of this study were to assess compliance with the developed treatment protocols through the dissemination of case studies. Out of 203 questionnaires distributed, 125 (62%) were collected. Community pharmacists were asked to complete case studies within a fortnight to indicate their line of action in three conditions presented. Average percentage compliance with the protocols was 73%.peer-reviewe

Extemporaneous preparations from the past

Compounding involves the preparation, packaging and labelling of a drug specifically for a particular patient according to a medical prescription. Until the mid-1900s, the compounding of such 'ondemand' pharmaceutical preparations, also known as extemporaneous preparations, was the basis of pharmacy. In Italy, in 1580, descriptive catalogues and standards for quality and uniformity of pharmacy formulas for pharmaceutical preparations were compiled. These became known as the 'pharmacopoeia' . In the 1930s and 1940s, about 60% of all drugs were compounded. However, in the 1960s, manual preparation declined. 2 The objectives of the study were to demonstrate different methods of preparations of various drug formulations irrespective of the active ingredients used and to compile a List of extemporaneous preparations that were compounded between the years 1955 to 1965.peer-reviewe

Proposing guidelines for responsible person eligibility in Malta

OBJECTIVES: To assess the current training and further education available to prospective Responsible Persons (RPs), to gather feedback from current RPs and industry stakeholders’ experiences and to recommend guidelines on what training and experience prospective RPs should undergo to become eligible for the role. METHOD: A focus group was organised with key stakeholders from the industry including representatives from the Medicines Authority, University of Malta and the Central Procurement and Supplies Unit (CPSU). Feedback on individual experiences was gathered. KEY FINDINGS: The most common recommendation from the focus group was the emphasis on the importance of having practical experience relative to the size and complexity of the operation. CONCLUSION: Guidelines to be proposed for a framework on accepting RPs should consider experience supported by knowledge on obligations and duties to be fulfilled by the RP.peer-reviewe

Critical analysis of the dispensing process at Mater Dei Hospital

Objective: To identify strengths and weaknesses within the present out-patient dispensing system at Mater Dei Hospital and to suggest alternative processes for a more user-friendly system. Method: Standard operating procedures (SOPs) were reviewed to obtain a better understanding of dispensing activities. Dispensing practices were observed and compared to SOPs. Strengths, weaknesses, opportunities and threats (SWOT) analysis was undertaken. Areas for improvement were evaluated through discussions with pharmacists and pharmacy technicians. Review of SOPs was undertaken to minimise non-conformance to SOPs and improve user-friendliness of the system. Key findings: The dispensing process is influenced by both internal and external factors in the pharmacy setting. Strengths from within the pharmacy setting are the availability of IT systems for record keeping and stock control and access to reference sources for medical and clinical information. Limitations to the dispensing process which should be considered include an environment where patient-pharmacist relationship and patient confidentiality are not supported due to large workloads, low staff levels and patient overcrowding. Whilst trying to encourage rational and safe use of medicines, the current system has an overload of bureaucratic procedures to the extent that these were perceived to limit pharmacists’ professional discretion. Current technological developments offer opportunities to improve pharmaceutical services, through bar coding and the integration of patient medication records from different health care settings. Conclusion: The potential contribution of the pharmacists to public healthcare has yet to be maximised, through the introduction of some flexibility of protocols to allow pharmacist professional judgement during the dispensing process.peer-reviewe

Storing medicines while reducing electricity consumption

Temperature storage requirements for medicinal products stored at room temperature were compiled. The rate of heat loss in a local pharmacy was investigated. Necessary measures required to achieve temperature controlled storage conditions in the most efficient manner were proposed. Energy efficiency together with carbon emission reductions were calculated.peer-reviewe

Smoking behaviour in pregnant Maltese females

The smoking behaviour of a randomly selected group of pregnant Maltese females attending the Antenatal clinic at Karin Grech Hospital, Malta was studied during the first four months of 1988. The group was also screened with regard to educational attainment, occupation and attitudes to smoking. It was found out that 45.4%, used to smoke before getting pregnant while 22.6% still smoked during their current pregnancy. The reasons for and the duration of the smoking habit are among the findings that are discussed.peer-reviewe

Standard operating procedures for quality control in the pharmaceutical industry

Objectives: To develop quality control standard operating procedures (SOPs) and to highlight the importance of implementation and use of these SOPs in the pharmaceutical industry. Method: A pharmaceutical company, Aurobindo (Swift services), was regularly visited three times per week over a five-month period. The visits consisted of familiarisation visits followed by visits for induction and specific training. A set of SOPs were selected, developed and implemented. Key findings: Nine SOPs were developed and implemented. Seven SOPs were developed using a simple format and two SOP s were developed in the form of flow chart. The average time taken to carry out a procedure was recorded and included in eight SOPs. Conclusion: SOPs are tools which when followed correctly ensure the consistency of a process. This is important in the pharmaceutical industry to achieve high standards of quality. Inclusion of the time taken to carry out a procedure gives an indication to the user whether the task was carried out as expected.peer-reviewe

A new approach to improve the yield in the production of slow release oral dosage forms

OBJECTIVE: The objectives of the study were to analyse a new improved method used for the production of pellets for the manufacture of solid oral dosage forms and to compare the new method with a method previously used and studied by Bartolo in 2011. METHOD: The parameters recorded during the production of slow release pellets were collected from the Batch Manufacturing and Instructions Record (BMIR). A total of eight batches were monitored and statistically analysed, using One Way Anova, to determine whether there is a statistically significant difference between the parameters of each batch. The mean surface rating of the pallets and the yield of the active pharmaceutical ingredient (API) obtained for the monitored batches, were statistically compared to those obtained in the previous study using the Independent Sample t-test. Statistical analysis was conducted using SPSS® version 20. KEY FINDINGS: Fine tuning in the control of all parameters during the manufacturing of different batches, even within established range, improves the yield of the final product. A statistically significant improvement in the mean pellets’ surface rating (p-value 0.004) and percentage yield of API (p-value 0.030) was observed in batches analysed in this study (4.75% and 94.09% respectively) when compared to batches analysed in the previous study (3.82% and 92.43% respectively) in 2011. The batches analysed during this study achieved the required dissolution rate after the application of the second slow release coating as opposed to the batches analysed in the earlier study, which required the application of a third slow release coating. CONCLUSION: The increase in the yield of API and improvement in the surface rating of the produced pellets implies that the new approach used for the production of slow release pellets is better and improved.peer-reviewe